QA Manager and Regulatory Affairs Officer in Bennet Pharmaceuticals Limited

Job Posted on Nov 11, 2017

Recruiter Type:Company
Company Name:Bennet Pharmaceuticals Limited
Address:6th Floor
B wing Manubhai Towers
Sayajigunj, Oppe MS University Vadodara
Contact Person:Siddharth Jain
Required in:Formulation Unit
Job Department(s):Quality Assurance, Regulatory Affairs
Job Title:QA Manager and Regulatory Affairs Officer
• Developing quality policy, standards and quality objective.
• Approval and control of all the master documents such as production, quality control and quality assurance documents, validation documents and standard operating procedures.
• Vendor development & qualification for active and inactive materials and packaging materials.
• In process quality checks at different stages of process.
• Release of finished product for sales and distribution.
• Change control, deviation, failure investigation, out of specification investigation, handling of market complaints and batch recalls.
• Corrective action and preventive action system is in place.
• Effective implementation of GMP across the facility.
• Evaluation and approval of validation protocols and reports of the manufacturing process, analytical methods and cleaning methods.
• Qualification/calibration of facility, utilities, equipments and instruments.
• Self inspection to ensure implementation of cGMP Practices.
• Handling of customer and regulatory audits
• Training to the personnel
• Annual product review
• Handling of retain samples
• Stability study development
Regulatory Exposure:Required
Audit Experience:WHO
Experience:5 years
Last Date:15/12/2017
Additional Details:regulatory Affairs Manager is required to prepare and co-ordinate with different plant locations for preparation and submission of dossiers
Note:Please send your resume to above email address to apply for this job.

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