Location: Ambernath, Maharashtra

Responsibilities:

• Issuance of various documents and maintaining tracking.

• Achieves Quality Assurance operational objectives by monitoring and reviewing LNB and Log Book for day-to-day activities, identifying and addressing gaps and problems and resolve the same.

• Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance.

• Responsible for Review of Raw and Packaging Material vendor documents like DMF, Vendor information form, Process flow, Stability data, GMP certificate, TSE/BSE etc.

• Support development and implementation of appropriate quality systems for MA and ANDA development activities

• Perform the review of development documents for MA and ANDA submissions, including tech transfer documents, product development reports, tech pack, analytical method development/validation protocols and reports, stability protocols and reports

• Responsible to provide Quality support at various stages of Product Development.

• Together with Product Development, provide guidance, oversight, and direction to external partners to ensure development activities are performed in a manner compliant with regulatory expectations

• Responsible for the co-ordination with Vendor, Purchase team and R&D team to resolve Development related product quality issues.

• Responsible for ensuring GLP compliance in the Laboratories as per the respective SOPs of site

• Ensure consistent performance of instrument and equipment by monitoring calibration and preventive maintenance which may have impact on quality of product. 

• Responsible for Contract testing laboratory, Contract Manufacturing Organization evaluation and Qualification for external development / testing / manufacturing activities.

• Responsible to perform audit of Raw Material Vendor, Contract testing laboratory, Contract manufacturing organization.

• Should have Knowledge about QBD Software

• Responsible for E software of Quality Management System

Qualifications & Experience

• BPharm or MPham, BSc or MSc with 5-8 years of relevant work experience

• Experience with vendor audit is mandatory