דרושים Representante Medico - Ecatepec Centro & Tlanepantla ב-טבע ב-מקסיקו

This incumbent

• Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
• Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
• Review of Instrument/Equipment Qualification records.
• Review of BMR.
• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
• Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
• Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
  Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

1. Review of CMC Documentation

• Review of Method Development / Validation protocols & reports.
• Review of Stability Study protocol, reports & grids.
• Review of Instrument / Equipment Qualification records.
• Review of Batch Manufacturing Records.
• Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
• Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
• Contemporaneous updation of SharePoint data base

1. Data requesting and Compilation of PQR’s

• Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
• Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
• Follow up with the CMO‘s for the receipt of data within time.
• Check quotation received from CMO and initiate PR/PO for QP’s approval.
• Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
• Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
• Contemporaneous updation of SharePoint data base

1. Quality Management Systems

• Initiate the process of change controls and deviations
• Preparation of local SOP’s and its related documents.
• Participate in self-inspection process

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 2 to 8 years of experience in QA / QC function in the pharmaceutical industry
• Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
• Basic knowledge on worldwide cGxP regulations
• Good English language skills, other language skills could be helpful
• Good communication skills
• Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
• Basic understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
• Hands-on experience on Review of Instrument/Equipment qualification records.
• Basic knowledge / hands on experience of review of BMR.
• Basic knowledge / hands on experience on Product Quality Reviews.

As Business Controller you work closely together with the Country Finance Lead and key stakeholders in the business to provide financial analysis & reporting, leadership and control on the commercial and financial activities in the geography, enabling effective decision making and strengthening compliance with relevant rules and procedures. Specifically:

• You own the Management Forecasting and Actual reporting process , from the Long Range Plan to the Annual Operating Plan, quarterly Rolling Forecast and monthly actual reporting, variance analysis and Upsides/Downsides identification
• You are the Business Partner for the Gx Business Unit and Ix Business Unit , providing financial insight and enabling effective decision-making that improves business performance and enhances sustainable competitiveness (e.g., Brand profitability, Sales & Marketing Expense ROI analysis and budget control, Portfolio decisions etc)
• You are a critical contributor to compliance with relevant financial guidelines (rules, regulations and corporate policies)

Planning, Forecasting and Management P&L Reporting for the country:

• Own the business planning process for the country (Gx & Ix), i.e. setting up meetings and templates etc to develop financial plans (AOP, RF, LRP), thereby ensuring that business and financial drivers are transparent and risks and opportunities are clearly identified.
• Set-up and maintain an efficient Management reporting (and planning) system for the country based on SAP BI as well as Hyperion system (Essbase/SmartView) as well as local tools & files.
• Provide professional insight, based on management reports and analysis, to the business unit, the cluster-leadership and Corporate Finance, ensuring a coherent financial picture that supports business decision management (e.g. clarity on drivers of deviation vs. AOP/RF etc.)

Business Partnership for the Gx/Ix Business Unit in the country:

• Develop and manage relationships with local business partners across all parts of the Gx/Ix Business Unit (Gx, Rx, Hx and OTC/Consumer Health Care), gain business understanding and provide insights based on financial data (e.g. gross margin analysis, brand profitability etc) that help in managing the business and improving the portfolio.
• Provide insight and guidance to the leadership team to support strategic planning and decision making regarding business opportunities and the company's pipeline.

Financial Compliance:

• Collaborate with the Finance Lead and the Accounting staff in the country to implement all applicable rules & regulations and internal policies (e.g. SOX, local tax regulations, corporate policies) and follow-up to ensure adherence.

People & Organization:

• Collaborate with Europe Controlling and the other markets’ business controllers to ensure adherence and quality in all routine Controlling Europe tasks (e.g. monthly Preliminary Net Sales submission, FTE submission, LBE submission etc).
• Actively share experience with other controllers in the cluster to continuously improve efficiency.

Academic background

• Min. Bachelor’s degree in Business Administration or Economics or Finance & Accounting or an equivalent combination of education and professional experience

Experience and knowledge

• For external candidates: A minimum of 2–4 years of relevant professional experience is required, ideally in the Pharmaceutical or FMCG sector within a mid to large matrix organization or a renowned auditing firm.
• For internal candidates: While prior experience in a similar role is an advantage, we also welcome applications from colleagues who demonstrate strong financial acumen, analytical thinking, and a solid understanding of our company’s systems, processes, and values.
• Additional requirements :
  • Solid knowledge of accounting principles
  • Practical experience in financial planning & analysis
  • Very advanced with Microsoft Excel
  • Knowledge of compliance and controls
  • Experience with SAP ERP-systems and Hyperion is an advantage
  • Fluency (speaking & writing) in English

Skills & Behavioral competencies

• Strong numeric abilities and analytical thinking
• Strong communication skills and customer orientation
• Ability to work independently and in a team
• Good planning & organization skills and excellence in execution
• Commercial awareness and adaptability to change

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This position is responsible for providing reliable and expedient results from the testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities in compliance with all regulatory requirements, company policies and procedures in compliance with cGMP and SOPs.

• Responsible for analysis of incoming materials, intermediates, finished products, swab samples, water samples, environmental monitoring samples, and other samples as needed.
• Responsible for preparing, maintaining, and reviewing data.
• Responsible for assisting senior personnel in investigations and root cause analysis for microbiology related deviations. Assisting senior personnel with laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Responsible for assisting senior personnel with revisions to documentation (including the use of Change Control) such as Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for assisting senior personnel with method suitability for compendial methods.
• Responsible for assisting senior personnel in the execution of complex projects such as method transfers, validations, and regulatory reports.
• Responsible for assisting senior personnel in projects of an advanced scope and complexity as assigned.
• Responsible for assisting senior personnel with communications with multiple departments including manufacturing, planning, and regulatory affairs.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a Bachelor’s degree, preferably in Microbiology or Biology, or equivalent education/experience.
• Prefer one to two years of relevant experience in a regulated laboratory environment.
• Prefer working knowledge of cGMP, DEA, and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Prefer experience with nonsterile pharmaceutical microbiology testing: Microbial Limits Testing (MLT)
• Prefer experience with water testing and environmental monitoring

Skills/Knowledge/Abilities:
• General understanding of the principles of microbiology as it applies to sterilization, bioburden testing, media preparation and qualification, aseptic technique, general traditional microbiology laboratory techniques.
• Experience with Gram staining and basic microscopy
• Computer proficiency with comprehensive working knowledge of MS Office products
• Ability to manage priorities and reporting requirements.
• Ability to perform routine tasks without direct supervision and perform non-routine tasks with some oversight
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.

Problem Solving:
• Proactively works on problems of a moderate scope where evaluation of contributing factors requires the analysis of situations or data and knowledge of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Manage and process Accounts payable transactions. Invoices processed in timely manner
• Manage the payment proposal creation and payment disbursement of scheduled payments timely
• Manage urgent payment requests on a timely basis
• Adhere to Internal controls prerequisite and ensure all approvals/ supporting are suitably documented
• Ensure compliance with company policies and procedures
• Create Payment batch for H2H payments processing.
• Collaborate with Treasury on payment cash flow forecasts required and to resolve payment issues
• Contribute to process improvements to improve process efficiency and drive automation
• Manage failed payments/ rejections
• Respond to Generic mailbox inquiries within the agreed Turnaround Time
• Positively and creatively influence change and champion mission critical change initiatives
• Participating in internal control testing and prepares documentation
• Prepare ad-hoc & operational reports, manage analytics & management reporting
• Support Accounts payable and periodic book close activities on time as per the close calendar
• Prepare an effective SOP to outline the procedure & scope in the prescribed template. Perform periodically review and sign off

• Bachelor’s/ Master’s degree in Accounting
• 0-1 years of working experience in Accounts payable Invoice processing and payment disbursements
• Excellent written and verbal communication
• SAP Enterprise knowledge with FICO and MM modules
• High level of attention to detail
• Good working experience in SAP workflow, Readsoft and Vendor portal
• Advanced Microsoft Excel skills, proficiency in MS office (PPT, VBA preferred)
• Good interpersonal skills to establish and maintain effective working relationships with a diverse population; ability to interact professional and courteously.
• Detail-oriented with the ability to manage multiple tasks simultaneously
• Flexible and adaptable to change, with the ability to work under pressure to meet deadlines in a fast-paced office environment .

Group Lead

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Carrying out dispensing activities as per applicable procedure.

• Responsible for recording the observation of reaction parameters on the batch card as per approve procedure.

• Filling of all the batch card ( production cleaning) as per approved instruction

• Ensure verification of pH meters and weigh balances as per applicable procedures.

• Maintain work procedure, safety precaution and cGMP.

• Ensure housekeeping of plant and cleanliness of the equipment, update the equipment.

• Report accident and irregularities at the work station to the Shift Officer. To prepare the production batch card, protocol and other relative document of production

• ERP operation related to Production activities.

• Carrying out batch processing including raw material charging, unloading of material and sampling activities during intermediate production.

• Coordinating with QA for Online compliance of GMP at shop floor.

• All other Production related activities advised by the Superiors from time to time.

• B.Sc./M.Sc. (Chemistry)

• 3 plus years' experience in API Production

• Candidate is flexible to work in shifts

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.