Career in Pfizer as Manager, COQA

Founded in 1849, 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 both people and animals. 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.

Post: Manager, COQA

Job Responsibilities:
The COQA Manager will have responsibility for quality assurance management of API contractors that manufacture or supply to Pfizer sites. Activities include but are not limited to the following:
1. QO interface on business teams managing contractors
2. Development and negotiation of quality agreements
3. Support the establishment and implementation of necessary QA/QC systems with contract manufacturers
4. Support technology transfer projects
5. Support development and maintenance of Pfizer quality systems
6. Support product release and troubleshooting quality problems
7. Support continuous improvement programs at contract manufacturers
8. Apply technical expertise in cGMPs during MSQA audits of contractors; independently develop action plans and lead negotiations with contractors to provide resolution of issues identified
9. Actively participate in and lead industry/regulatory forums on contract manufacturing oversight and networking both inside and outside of Pfizer

Qualifications:
A minimum of a Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy or related science s required. Masters degree preferred

Experience:
1) A minimum of 10-12 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience is required, preferably with prescription products and a minimum of 10 years applicable product quality assurance experience.
2) An experience to API and / or contract manufacturing QA is preferred
3) Supervisory experience and an experience in QC is desirable
4) Demonstrated ability to apply global cGMPs and QA/QC system requirements, practices, and theory, preferably associated with manufacture of Human products
5) Demonstrated experience in managing quality and compliance activities in a manufacturing plant or with a contractor
6) Demonstrated ability to manage multiple projects, prioritize work for self, and accomplish the demand need.
7) Demonstrated leadership capabilities, accountability, and ability to resolve conflict

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Competencies:
This position interacts with high levels of management at contract manufacturers and is a visible Pfizer representative. This is an highly independent roke with minimal supervision. This role will operate as a spokesperson for COQA India and significant time is spent developing relationships, negotiating issues, and communicating Pfizer quality requirements with contract manufacturers. The Manager COQA will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GMC, GTS and PGRD) and will work closely with cross functional teams such as Co-Development Teams and New Product Introduction Teams.

Demonstrated project management skills. Good organization skills, analytical thinking and interpersonal communication skills. Trustworthiness, cooperation and flexibility interacting with many different organizations. Demonstrated personal leadership and accountability. Advanced computer skills and MS office are required. SAP and other enterprise platform knowledge is an advantage. 30% travel required.

Additional Information
Experience: Min.10-12 Years
Education: B.Pharm, B.Sc, Any
Job ID: 1000749
Functional Area: Production
Location: Thane
Last Date: 26^th Aug, 2014