Qualified Person and Senior Quality Manager
Pfizer SA
Région
Contrat
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.
You will provide QP certification and release activities include lots received from both Hospira and third party manufacturing facilities, both within and outside the EU. The function serves to conduct remote, virtual batch certification and release activities on associated lots.
Compliance and Integrity:
You will be responsible for conducting your activities on behalf of the company consistent with a high standard of business ethics and in compliance with the laws and regulations that govern our activities. Your obligation encompasses the following:
- Takes personal responsibility for and demonstrates a high level of understanding of and adherence to the applicable internal policies, including but not limited to our Code of Ethics and Business Conduct and other policies applicable to your job, and external laws and regulations governing your activities.
- Exhibits high business ethics standard in dealing with internal and external stakeholders, including dealing with others honestly and openly, showing accountability, being reliable and trustworthy and being loyal to the company.
- Completes all required compliance and ethics related training within required timelines.
Essential Job Functions:
- Eligible to act as a European Qualified Person in Belgium as per Royal Decree 14 December 2006, certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16, with relevant experience in Sterile Injectable dosage form manufacture and testing
- Execute drug product batch certification and release functions in compliance with 2001/83/EC, 2003/94/EC and Annex 16
- Review of batch manufacturing records and other documentation associated with QC release in conjunction with QA Officers. Checking that batch manufacturing records comply with registered details and EU GMP standards. Investigating any differences or issues found upon review of the batch manufacturing records and rectifying problems in conjunction with relevant sites and personnel.
- This is an individual contributor role
- Location: Zaventem (Belgium).
Your skills
- Education: Bachelor's degree in a related scientific discipline with relevant experience (Biology/Chemistry/Pharmacy/Life Sciences)
- Experience: Trained as QP with experience in pharmaceutical materials.
- Experience of API manufacture, primary compounding, primary and secondary packaging and release, preferred.
- Experience in validation of facilities, utilities, equipment, processes, analytical methods
- Extensive knowledge of GMP & GDP
- Eligible to act as a QP in Belgium as per Royal Decree 14 December 2006 in association with an MIA.
- QA Management / line management experience
- Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.
- Languages: English, French and/or Dutch
At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.
We offer possibilities for working from home (up to 3 days per week) and flexible working hours.
Competitive salaries and benefit packages : DKV insurance, pension plan, in-company restaurant, phone, company car.
Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. Should you have any question or specific needs regarding this hiring process, please contact : [email protected]. We kindly ask you not to use this email address to apply. Interested? Click on the "apply" button !
For our projects regarding diversity and inclusion on the work floor, Pfizer is collaborating with Actiris and other partners.