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Experience:
10 - 14 Years
Location:
Mumbai
Compensation:
No constrain for the right candidate .
Education:
UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy,M.Sc - Chemistry
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
QA/QC Mgr
Functional Area:
Production, Maintenance, Quality
Posted Date:
29 Apr
Desired Candidate Profile
M.Pharma / M.Sc. with 10 to 15 years experience in Quality Assurance,Regulatory Affairs or compliance auditing in the pharmaceutical industry. The incumbent must possess an understanding of and the ability to apply cGMPs and risk management tools. Excellent oral and written bilingual communication skills are essential. The ability to work independently against multiple deadlines is required.
Job Description
The incumbent will be responsible for 1- Manage quality compliance activities, which include coordination of the regional audit schedule, audit planning, deliverables, and quality oversight of Rx nd CHC suppliers and finished dosage forms manufacturers in the Asia Pacific region (India), and other related work as assigned.
2- Execute a quality and compliance master plan for the quality with Asia/Pacific finish dosage form manufacturing partners.
3- The quality and compliance master plan is to assure manufacture of finished dosage forms meeting the consistent quality standards and compliance requirements suitable for distribution in the United States and other countries where Perrigo chooses to market and distribute products.
4- Performs assessments, determines gap analysis, and implements strategies, organizations, relationships, and quality systems at the manufacturing facilities to fully comply with applicable U.S. FDA or other Countries’ health ministries’ regulatory and quality requirements.
5- Manage the resolution of deviations, operational, technical and quality issues directly under the guidance of or through liaison with business operations.
6- To act as the liaison between external manufacturers and business units/site operations for commercial product launches and method/tech transfers.
7- To assist in the investigation and resolution of quality, compliance, regulatory and technical issues at external manufacturer and to develop and report supplier quality performance metrics
8- To promote and build a “Quality Culture” through training (show and tell) and examples
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