

This individual will work closely with strategy pillar leads, business analysts, finance, and functional stakeholders to ensure plans and programs are accurately captured, tracked, and aligned. The role is highly collaborative and requires deep coordination across functions and geographies, as well as strong process governance capabilities.
SKILLS AND EXPERIENCE
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.
משרות נוספות שיכולות לעניין אותך

Background:
Skills:
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.
משרות נוספות שיכולות לעניין אותך

Medisspecializes in out-licensing high-quality generic pharmaceuticals to third-party pharmaceutical companies. Established in 1985, we offer a broad portfolio of 170+ generic pharmaceutical products, mainly in the form of tablets, capsules and injections.
Our portfolio includes a growing range of specialist oncology products and product formulations, predominantly solid oral dosages.
As ayou will play a critical role in developing market strategies in your responsible market (Italy), leading and executing in market B2B business development and key account management within the pharmaceutical space.
Medis European Markets Cluster Head
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.
משרות נוספות שיכולות לעניין אותך

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With
the industry's broadest portfolio including over 350 API products, TAPI is the go-to global
We are looking for a Sr Manager, Microbiology-Quality Compliance Expert - TAPI.
The main purpose of your job will be to ensure that the Microbiology laboratories, systems , procedures related to Quality Compliance System at TAPI sites is in place, securing compliance of activities, OOS investigations, Micro CCS, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly.This role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance related to Microbiology and other quality compliance support, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites.
• Support the Implementation of the Site Inspection Readiness Program focusing on Microbiology labs and related areas
• Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)
• End to End Support for Health Authority Inspections focused on Microbiological aspects
• Support the Implementation of Quality Risk Management
• Review and Monitor Quality Improvement Plans
• Train Site Colleagues on the Microbiology fundamentals, investigations, and Corporate Standard System
• Support Global Quality Compliance Initiatives eg; Cross contamination strategies
• Data Reliability assessments, gap evaluations, GxP data mapping in the micro labs
• Review global TAPI policies and standards and provide inputs
• Expected to spend reviewing QMS areas outside microbiology subject that related to QIPs, Data trending, signal detection, managing quality forums, leading CoPs related to Microbiology and relevant Quality management systems ( CAPA, Investigations, QRM etc)
• Establish and monitor governance on data integrity requirements.
• Cooperate with other functions on Quality projects and their role out.
• Act as a quality SME and support global compliance initiatives upon request
• Participate in audits upon request.
• Fosters knowledge sharing among sites within the TAPI
• Degree in Industrial Microbiology and demonstrated knowledge in cGXP regulations.
• 10+ years' experience in GMP environment, continuous professional development 5+ years' experience in Microbiology laboratory, managerial tasks, organization Exposure to International working environment
• Mix of experience in Micro, Quality systems would be preferred.
• Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, etc.
• Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including US FDA, PMDA and ANVISA requirements
• Performance management and reporting
• Project management, monitoring, execution and reporting
• Problem solving and good team work skills
• Proactive orientation, communication skills
• Proven influencing capabilities
• Fluent in English
TAPI will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.
If you are a current TAPI employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to TAPI employees. Use the following link to search and apply:
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.
משרות נוספות שיכולות לעניין אותך

Reporting to the Quality Assurance Manager, you will contribute to maintaining the effectiveness of the Quality System at the site.
In your day-to-day, you'll be responsible for:
Batch Disposition:Review batch documentation for compliance before disposition and Manage disposition of raw materials, intermediates, and final APIs with Qualified Person's support.
CAPA:Review, approve, and ensure timely execution of CAPAs to prevent reoccurrence of issues and Implement remediation actions assigned to Quality Assurance.
Complaints:Investigate complaints with Site Quality Head, Qualified Person, and QA Manager and Issue and review complaint reports, notify suppliers of complaints.
Deviations: Investigate deviations with Site Quality Head, Qualified Person, and QA Manager and Issue and review deviation reports, support investigations.
Notifications to Management:Collect and verify information for management notifications.
Quality Overview & Shop Floor:Ensure quality oversight and monitoring at shop floor, participate in Quality Walk Arounds and Audit production and warehouse operations for compliance.
Quality Shipment/Logistics:Manage and review packaging and shipping documentation and Approve packing lists with Qualified Person's support.
MS&T and RA Support:Review batch documentation per regulatory requirements and Verify manufacturing and packaging processes align with DMF.
APR/PQR:Prepare and issue Annual Product Reviews, share schedules with other sites and suppliers and Review APRs provided by service suppliers.
Change Control Management:Evaluate and implement changes with Site Quality Head, Qualified Person, and QA Manager and Issue, review, and approve risk assessments for change controls.
Cleaning Validation Review: Review documentation for equipment cleaning procedures.
Document Management:Manage and distribute manufacturing procedure/master batch records and Archive executed batch records.
Process Validation Review:Review and approve documentation for manufacturing process validation.
Compliance Support:Participate in regulatory audits and support Inspection Readiness Plan.
Education
• Bachelor’s degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required.
• Alternatively, a High School Diploma completed by relevant and verified Training/Certification for the role can be accepted on an exceptional basis.
Skills
• Able to work with a good level of autonomy with supervision where necessary
• Ability to work cross-functionally.
• Familiar with Quality IT Systems: i.e. TrackWise
Languages
• Italian, proficient English
Minimum Experience / Training required:
•3-6 years of work experience in API/pharmaceutical companies.
QA Manager.
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.
משרות נוספות שיכולות לעניין אותך

In the QC Department we are looking for a brilliant profile reporting to the QC Manager with the following responsibilities and activities:
Coordinate a group of supervisor and lab analysts:
University degree in Chemistry, Pharmacy or CTF
Skills:
English and Italian (level of proficiency)
Minimum Experience / Training required:
Minimum: 4 years work experience in Quality Control
We try to take care of our employees, offering them small and large benefits. By way of example:
Type of contract: long term contract
Santhià (VC), from Monday to Friday
משרות נוספות שיכולות לעניין אותך

This individual will work closely with strategy pillar leads, business analysts, finance, and functional stakeholders to ensure plans and programs are accurately captured, tracked, and aligned. The role is highly collaborative and requires deep coordination across functions and geographies, as well as strong process governance capabilities.
SKILLS AND EXPERIENCE
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.
משרות נוספות שיכולות לעניין אותך