Title:  Manager - Quality Assurance

Position: Sr Executive / Manager – Quality Assurance

Grade: G11B / G11A

No. of Position: 1 No.

Job Location: Ahmednagar

Qualification: B.E. (Chemical) / M.Sc. (Chemistry)

Experience: 8 to 10 yrs experience in B.E. (Chemical) / M.Sc. (Chemistry) of API manufacturing plant

Job Profile

• To participate in various investigation as applicable. To review and approve assessment report, investigation reports for change control, OOS, incident, deviation, market complaint and risk assessment.
• Responsible for imparting of trainings to Quality and cross functional teams.
• Review and approve of GMP documents related to activities like Batch release COA, BMR, Annual product Quality Review.
• Review, approve transitions in software’s like, EDMS, Track wise, Metis, SAP, HANA and SAP.
• Review and approval of SOP, protocol / report of process validation, cleaning validation, equipment qualification, AHU/HVAC qualification, water system validation, area qualification, temperature mapping, various layouts and software validation protocol/reports, vendor qualification documents, evaluation of supply for quality (Q Score) and vendor annual risk assessment, VMP, PPQMP and CVMP as and when required.
• To follow safety and use of required personal protective equipment during day to day activities.
• To conduct new Employee induction training / cGMP training / SOP training
• To carry out any other responsibility assigned from time to time orally or in writing by reporting authority by ensuring completion of required tracking.
• Ensure the quality policies, standards and procedures for implemented and adhered at site.
• Review and approve the documents as per quality procedures.
• Review / support to draft response of internal / external audit observations for systems and ensure its compliance.
• Ensure the QMS (Deviations, Change Control, CAPA, incidences etc.) related to systems are closed in timely manner.
• Work in partnership with the site cross functions and corporate functions for implementation of new initiatives for systems.