Lead Gpv Professional Icsr Quality & Metrics jobs at Teva in Romania, Bucharest

As Lead GPV Professional, you will support Pharmacovigilance Data Quality and Case Processing Metrics, ensuring accuracy, compliance, and inspection readiness across global PV operations. Reporting to the ICSR Quality & Metrics Team Lead, you will drive oversight, analysis, and continuous improvement of ICSR processes while collaborating cross-functionally to enhance data integrity and operational excellence.

• Ensure compliance with global PV regulations and internal policies, owning key SOPs, WIs, and JAs.
• Strengthen ICSR Quality & Metrics by maintaining data integrity, inspection readiness, and seamless submissions.
• Transform data into insights by analyzing reports (e.g., QlikSense, V-Safe) and driving meaningful improvements.
• Collaborate with cross-functional teams to enhance compliance reporting and streamline processes.
• Lead projects that improve case quality, compliance, and performance.
• Act as a business owner for selected GPV tools, shaping the SDI strategy.
• Promote continuous improvement through root-cause analysis and innovative solutions.
• Share knowledge, mentor others, and help the team reach its annual goals and KPIs.

• Minimum Master's degree in Life Sciences or another related field.
• Minimum of 3 years of Biopharmaceutical/CRO industry experience, including a large international organization.
• At least 1 year of direct people/project leadership experience.
• Experience in handling Health Authority Inspections.
• Project Management experience is an advantage.
• Fluent in English.

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.

• Overall responsibilities for activities of engineering.
• Monitoring / review of procedures, cGMP records in engineering store and to ensure compliance.
• Prepare / review of Engineering store SOP’s in Glorya Electronic Data Management System.
• To ensure readiness of the department for regulatory inspections and ensure their compliance.
• Up keeping of engineering store compliance.
• Initiation / execution of Change Controls, Deviations, Investigations, CAPA’s in Trackwise System for engineering store and its timely closure.
• Follow up for any deficiency and corrective actions.
• Physical stock verification and it’s reconciliation to confirm the availability of stock for effective procurement of material in co-ordination with cross functional departments and share the list of materials availability monthly once to immediate supervisors.
• Upgradation / maintenance / alteration / renovation of engineering store facility in coordination with engineering department.
• Monitoring of receipt / issuance of miscellaneous, UD clearance of materials/miscellaneous, consumables and ancillary materials and its documentation.
• Ensure verification of physical inventory count as per inventory count cycle.
• To motivate the team member for reporting of near miss events and non-safety incidents.
• Monitoring of disposal of scrap from scrap yard area and up keeping of scrap yard.
• Monitoring of disposal of miscellaneous/chemical process as per standard procedure in engineering store with its documentation and controls.
• Printing/pasting of quarantine labels on ancillary materials.
• Ensure compliance of material handling in engineering store as per SOX.
• Ensure compliance to the requirement of policy and procedure on data integrity.
• Handling of SAP R/3 System (engineering store related transactions), Trackwise System and Glorya Electronic Data Management System (as applicable).
• Ensure all assigned training requirements are completed in learning platform (Studium).
• Co-ordination with cross-functional departments for smooth functioning of department activities.
• Ensure departmental safety by giving the awareness training for handling of miscellaneous, consumables and ancillary materials to the engineering store persons and implementation of good safety practices in engineering store.
• To follow the normal safety precautions in working area and ensure departmental safety at all times.
• Responsible for maintaining disciplined work culture in working area.
• Ensure compliance to the requirement of policy and procedure on data integrity.
• Any other responsibilities assigned by the reporting authority.

• Education /Qualification: Diploma / Degree in Engineering
• Experience: 7- 9 years of relevant experience

We are seeking an experienced and strategic EHS Lead (Associate Director) to oversee and continuously improve our Environment, Health, and Safety programs at the factory level. This is a key leadership role responsible for ensuring compliance with Romanian legislation and corporate policies, while fostering a culture of safety, sustainability, and operational excellence. You will also coordinate Business Continuity Management (BCM) and administrative functions, playing a vital role in protecting our people, assets, and the environment.

You bring over 5 years of hands-on experience in EHS, with at least 3 years in a leadership role.
You’ve successfully managed complex safety systems in a regulated environment and have a strong track record in implementing ISO standards, managing audits, and leading cross-functional teams.
Your ability to balance strategic oversight with operational execution makes you a trusted advisor and effective leader.

- University degree in a relevant field.
- Specialized certifications in occupational safety and environmental protection.
- In-depth knowledge of Romanian OHS and environmental legislation.
- Proven experience with ISO 14001 implementation and EHS audits.
- Strong leadership, communication, and team coordination skills.
- Experience managing budgets, KPIs, and performance metrics.
- Fluent in Romanian and English (written and spoken).
- Familiarity with GMP compliance and manufacturing best practices is a plus

Curs în domeniul securității și sănătății în muncă
Curs evaluator de risc SSM
Curs Cadru Tehnic PSI
Curs Inspector de mediu si Responsabil Gestionare deseuri

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.

• Acting as the Responsible Person (RP), ensuring full compliance with GDP, national and EU pharmaceutical regulations, and narcotic distribution laws.
• Independently overseeing market release, recalls, and complaints related to medicinal products.
• Leading quality management processes, including audits, SOPs, CAPAs, change control, and documentation systems.
• Communicating directly with national health authorities and hosting inspections with full readiness at all times.
• Maintaining licenses and authorizations related to medicinal and narcotic products, including reporting to authorities.
• Providing strategic quality guidance and partnering closely with the General Manager and cross-functional commercial teams.
• Leading and executing risk management activities across the distribution chain.
• Participating in European-level quality councils and ensuring implementation of regional initiatives locally.
• Ensuring continuous GDP training, quality awareness, and inspection readiness.
• Being the key local quality contact for both internal stakeholders and external regulatory bodies.

• Master’s Degree in Pharmacy, Medicine, or Biology (Pharmacist license mandatory); advanced degrees are a plus.
• Minimum 3 years of experience in a RP, QP, or QA Manager role in a pharmaceutical company, ideally in a large international organization.
• Proven ability to work independently, with full ownership of RP and QA responsibilities.
• Strong understanding of GDP, GMP, and Romanian/EU legislation including those related to narcotic substances.
• Experience managing health authority inspections, quality systems, and regulatory submissions.
• Excellent communication skills and ability to influence at all levels of the organization.
• Track record of implementing quality systems, continuous improvement, and issue escalation.
• Fluent in English; Romanian language proficiency is essential for regulatory communications.
• Strong problem-solving, decision-making, and risk assessment capabilities.

• Competitive compensation package aligned with experience.
• Benefits package: meal vouchers, healthcare subscription to a private clinic.
• Highly professional team and organizational culture with strong values.
• Professional development within the company.

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.

Sindan is looking for the futureUtilities Maintenance Leadwho will have the following main responsibilities:

Responsible for plant's utility assets, equipment and systems (such as high voltage electricity infrastructure, cooling&heating systems, gas systems, HVAC, Steam (black&clean), water, communication, in aspects of reliability, availability and value preservation in order to accomplish the goals of production.
Responsible for execution of CAPEX projects: Implementation of system and equipment in accordance with regulatory requirements, engineering standards (budget, time, scope) and Good Manufacturing Practice (cGMP).

Site Utility management and optimization: Manages the business of the utility maintenance having end-to-end responsibility for achieving the facility equipment and system's reliability, availability and value preservation.
EHS&S and cGMP compliance: Ensures the implementation of Standard Operating Procedures relating to utility assets, equipment and system maintenance, and compliance with local/global requirements of Quality, EHS&S and Good Manufacturing Practice (cGMP).
Budget management: Plans and monitors utility operational budget of maintenance and staffing.
People Management: Manages a team of utility maintenance employees, ensuring their proper level of competencies and supporting their development.
Supplier/Contractor Management: Responsible for communication and relationship with equipment suppliers and maintenance services as well as internal stakeholders such as Procurement.

Manages the business of the Utility Management organizational unit:
Responsible for supervision, maintenance and support of the plant's utility assets, equipment and systems, to support the business goals.
Establishes process standardization to ensure managing and maintaining equipment and systems in compliance with good engineering practice, EHS&S and cGMP standards.
Manages, plans and monitors the utility operational budget. Identifies and maintains required spares to ensure proper functioning.
Exercises management authority; including recruitment, discipline, termination, sets employee performance objectives, conducts performance reviews and recommends pay actions. Ensures employees' proper level of competencies and support their development.
Responsible for equipment and maintenance supplier relationship. Ensures legal compliance with authorities' requirements, permits etc
Strives to continuously improve the business, ensures functional requirements are met, and support new implementation of facility equipment and systems when needed.

Technical experience in project management in the Pharma/medical equivalent industry
industry
A minimum of 6 years in the pharmaceutical industry
Minimum of 3 years of managing maintenance departments

Well familiar with pharmaceutical industry regulations and requirements, including quality and EHS&S in the scope of engineering.
An academic BSc engineering degree from a well-known academic institution in mechanical, chemical, or another relevant field. (electronic, industrial, etc.).

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.

Sindan is looking for the futureEquipment Maintenance Leadwho will have the following main responsibilities:

Responsible for manufacturing assets and equipment, in aspects of reliability, availability and value preservation in order to accomplish the goal of production.
Responsible for execution of CAPEX projects: Implementation of system and equipment in accordance with regulatory requirements, engineering standards (budget, time, scope) and Good Manufacturing Practice (cGMP).

Site production equipment management and optimization: -
Ensures that assets, equipment and systems in the plant are available, qualified, and functioning to meet site KPIs.
Maintenance and supervision of equipment operation and processes, as well as infrastructure elements within the area of activity of maintenance of equipment and systems.
EHS&S and cGMP compliance: Ensures the implementation of Standard Operating Procedures relating to equipment and system maintenance, and compliance with requirements of Quality, EHS&S and Good Manufacturing Practice (cGMP).
Budget management: Plans and monitors equipment operational budget of maintenance and staffing.
People Management: Manages a team of equipment/maintenance employees, ensuring their proper level of competencies and supporting their development.
Supplier/Contractor Management: Responsible for communication and relationship with equipment suppliers, maintenance services and OEMs, as well as internal stakeholders such as Procurement. Ensures legal compliance with authorities requirements, permits etc

Manages and develops the business of the Production Equipment Maintenance organizational unit:
Responsible for supervision, maintenance and support of the plant's production equipment, to support the business goals.
Accountable for ensuring the equipment reliability and availability, and plays a critical role in safeguarding the assets of the organization and ensuring the uninterrupted operations of the business.
Establishes process standardization to ensure managing and maintaining equipment and systems in compliance with good engineering practice, EHS&S and cGMP standards.
Manages, plans and monitors the equipment operational budget. Identifies and maintains required spares to ensure proper functioning.
Exercises management authority; including recruitment, discipline, termination, sets employee performance objectives, conducts performance reviews and recommends pay actions. Ensures employees' proper level of competencies and supports their development.
Responsible for equipment and maintenance supplier as well as OEM relationship. Ensures legal compliance with authorities' requirements, permits etc
Strives to continuously improve the business, verifies preventive maintenance, ensures functional requirements are met, and supports new implementation of equipment to support the business needs.

Technical experience in project management in the Pharma/medical equivalent industry

A minimum of 6 years in the pharmaceutical industry
Minimum of 3 years of managing maintenance departments

Well familiar with pharmaceutical industry regulations and requirements regarding quality and EHS&S in the scope of engineering.

An academic BSc engineering degree from a well-known academic institution in mechanical, chemical, or another relevant field. (electronic, industrial, etc.).

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.