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Associate - Quality Compliance

2 weeks ago

Chennai, India Pfizer Full time

Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture, and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments, and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

This role will support the Logistics Center Quality Director in daily activities related to quality logistics within the Intercompany Organization. This role is responsible to ensure the continuity of daily operations linked to supply of materials under the responsibility of Supply Point Company managed by Logistics Center Zaventem. This role is responsible to handle according to procedures and follow strict compliance with GDP legislation.

Roles and Responsibilities:

- Quality Inventory Management
- Support the batch disposition in SAP following CoC check, psychotropics, narcotics and returned goods.
- Support the inventory changes in SAP following cycle count
- Follow-up of shipments under quarantine and ensure alignment with R-ship table and perform quality movements in SAP linked to SLOC changes (returns, destruction, serialization, T° excursions )
- Support the SSA for administrative releases and metrics reporting for quality inventory management.
- Provide maintenance of quality systems and associated electronic system changes
- Support change management activities relating to site compliance activities
- Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GxP

Support inspection readiness for BOH inspections and external vendor audits
- T° excursion management
- Support the management of T° excursions during transportation
- Maintain the database of stability memo’s supporting T° excursions
- Timely follow-up and closure of records in QTS-LC related to T° excursions
- Support the SSA for T° excursion management
- Support the metrics reporting for T° excursion management

Qualifications:

- University Degree in Systems, Advanced Analytics, Supply Chain, Logistics or Business Administration (Management), Post-Graduate degree preferred. A degree in another field may be considered if accompanied by appropriate work experience.
- Min of 1-2 years of experiences in Supply Chain, Logistics or Transportation in an international environment with preference of Pharmaceuticals or high-volume consumer goods industry is preferred, but not mandatory
- Strong interpersonal and communication skills.
- Ability to work autonomously as well as in teams; including multi-functional and geographically dispersed project teams. Willing to work flexible hours to support global operations.

**Skills**:

- Demonstrated collaborative, consultative, problem solving, prioritization and analytical skills.
- Technology systems proficiency and/or ability to quickly master technology.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control