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Vacancy for Manager Quality Compliance in Pfizer

 

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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 Quality Compliance

Job Description
1. Identify and resolve quality, process, and GMP problems;
2. Manage overall process in evaluating site compliance and implement appropriate actions;
- Investigations
- Process Validation & Packaging Validation
- Supplier Management
- Internal Audit
- Annual Product Review
- Complaint Management
- Training
- In-process Quality Assurance
- Quality Risk Assessment
- Equipment Qualification  
3. Manage the overall assurance and disposition of products produced in the site
4.  Update & Review  quality assurance reports and investigations for deviations from approved manufacturing processes or specifications;
5. Review key quality and regulatory documentation and implement appropriate actions,
6. Participate and submit data to the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance
7. Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues;
8. Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and discussions;
9. Manage the financial performance of the quality department and support both department and site Cost Improvement Projects (CIPs) to ensure goals are achieved or exceeded;
10. Be a voice for change and continuous improvement.

Audits Experience:
• FDA, ISO, WHO, WHO Geneva  and Regulatory Audits

Qualification & Experience:
Master degree in pharmacy with at least 10 years directly related experience in pharmaceutical manufacturing and quality assurance, or equivalent combination of work experience

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Other activities
- Exceptional understanding of GMPs and demonstrated leadership management, coaching, development and technical capabilities.
- Strong verbal, written, presentation, interpersonal, and communication skills. Proven ability to plan, implement, and achieve significant, complex goals and objectives.
- Demonstrated commitment to achieving objectives in a manner that is supportive of Pfizer Values and PGS mission elements.
- Desirable to have exposure to lean, Six Sigma and Transformation.

Additional Information
Experience: Min. 10 Years
Qualification: M.Pharm
Job ID: 1009502
Functional Area: QC
Location: Goa
Last Date: 17th March, 2015

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