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 - MSQA Audit
To conduct audits and assesments of suppliers, contractors, and facilities for MSQA.
1. As assigned, independently conducts or assists in conducting quality audits / assessments of facilities to evaluate the following:
a) Adherence to the concepts of GMPs and, for Pfizer contract manufacturers, compliance with policies, regulations and Pfizer expectations;
b) Adequacy of facilities and equipment for intended use;
c) Management attitude toward quality and compliance with applicable requirements;
d) Whether personnel are properly educated and trained for their responsibilities;
e) Adequacy of production and control procedures to ensure the identity, strength, quality and purity of the finished product;
f) Weaknesses that could lead to manufacturing and distribution of products in violation of the relevant laws and regulations.
2. Recommends corrective actions.
3. Reports audit findings in writing to Management at audited site and to Pfizer Management.
4. Performs follow-up.
5. May assist in training Pfizer Site Auditors.
6. Maintain the MSQA database of audited suppliers.
7. Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards.
Bachelors Degree (or local equivalent), preferably in pharmaceutical or natural sciences, or equivalent EXPERIENCE
Total Work Experience:
1. 5-10+ years industry or other relevant experience (including quality control/assurance, manufacturing, regulatory affairs or product development) and auditing experience
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Skills & Competencies
1. Familiarity with CGMPs (pharmaceuticals, foods, cosmetics)
2. Experience with working outside of Quality Operations in areas such as API manufacturing, dosage form manufacturing, packaging and EHS.
3. Familiarity with the India culture and India business environment
4. Fluency in English
5. Familiarity with computer systems
6. Problem solving ability
7. Excellent oral and written skills in English
8. Strong interpersonal skills
9. Ability to work with and retain information of a confidential nature
10. Ability to travel (40%)
Experience: 5-10 Years
Job ID: 984400
Functional Area: QA
Last Date: 18th Aug. 2013
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