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: Senior Manager MSQA Audit
1. As assigned, independently conducts audits and assessments of raw material suppliers, contract manufactures, and PGS facilities:
a. Adherence to the concepts of GMPs and compliance with requirements in the quality agreement and with Pfizer expectations.
b. Continued adequacy of the facilities and equipment being used for manufacturing.
c. Management attitude toward compliance with applicable requirements.
d. Review the turnover of employees and assess whether employees are being properly trained for their responsibilities.
e. Weaknesses that could lead to manufacturing and distribution of products in violation of the relevant laws and regulations.
f. Assuring that the supplier is executing all activities (manufacturing, testing regulatory compliance) per Pfizer agreements.
g. Communicate relevant quality, EHS and business information to the supplier in an effort to maintain and enhance the relationship between the supplier and Pfizer.
2. Participate in Pfizer audits at the supplier, . Responsibilities for this activity include:
a. Assisting in scheduling the audit.
b. Actively participating in the audit as directed by the lead auditor.
c. Review the audit report to the supplier and assist in developing acceptable remediation plans.
d. Performs a follow-up as needed or as directed by PGM leadership
3. Maintain the appropriate database with any relevant information pertaining to the supplier.
4. Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards that could impact the supplier.
5. Liaise between the supplier and the appropriate Pfizer group to ensure that any and all pertinent information is communicated such as any regulatory activity, any changes that are requested by Pfizer or the supplier or any pending or active regulation that may have an impact on the supplier’s or Pfizer’s business.
6. Conduct and participate in due diligence site assessments as required to determine vendor suitability.
7. Work as needed with PGS leadership and the appropriate Pfizer departments to develop/review plans to be implemented at a supplier in the event that closer scrutiny of the supplier is required.
Education: Bachelors Degree (or local equivalent), preferably in pharmaceutical or natural sciences, or equivalent
1. 5-10+ years industry or other relevant experience (including quality control/assurance, manufacturing, regulatory affairs, or product development) and auditing experience
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 (ability to recognize symptoms of problems or situations that require further evaluation, analyze symptoms to determine potential causes, suggest possible corrective actions)
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 relevant experience
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
Job ID: 951471
LAST DATE: 13th July, 2011
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