Sr. Executive - Quality Assurance For Pharma Formulation Co. Pune

Role & responsibilities

• Total responsibility of QA at site.
• Preparation and continuous improvement of company Site master file and its annexure.
• Preparation and maintenance of validation master plan in consultation with other dept its annexure.
• Preparation, revision and approval of QA department SOPS.
• Review and approval of other department SOPS.
• QA SOP training to all Department Employee.
• Timely investigation and closure of Market complaint/Product Recall..
• To develop and implement Quality management system in plant.
• Preparation, review and approval of QMS documents and related evaluation.
• Evaluate and authorise master manufacturing and packaging documents.
• Review and approval of Qualification protocols and reports of Machines, Equipment and Instruments.
• Review and approval of qualification protocols and reports of HVAC system
• Review and approval of water validation protocols and reports.
• Review and approvals of Area qualification protocols and reports.
• Review and approvals/Retrieval/Archival of Master BMR and BPR of Oral dosage and external preparation product.
• Review and approvals of Master MFR of Oral dosage and external preparation product.
• Review and approvals of process/Cleaning validation protocols and reports and to ensure the appropriate validation are conducted.
• Review of BMR , BPR & QC reports for release/Hold and reject of batch.
• Review and approval of Hold time study protocols and reports and its implementation.
• Review and approvals cleaning validation protocols and reports.
• Implementation of cGMP practices in the plant.
• Development/Implementation of Good documents practices in the plant
• To maintain audit compliance report of all regulatory and local agencies.
• Plan and conduct scheduled self Inspection of all departments and maintain its compliance.
• To work independently in absence of Quality Head.
• Handling non compliance and incidence in the plant.
• Review and approval of APQR of Oral dosage and External preparation.
• To Participate in vendor audit programme
• Handling Item code generation of RM, PM & FP and maintain master list.
• Batch number allocation to new products.
• Any other task which is given to you by your senior in case of emergency.

Required Candidate profile

1. 06- 08 years of experience in Formulation Pharmaceutical Plant.

2. Relevant Experience in Pharma formulation plant.

3. Computer proficiency in MS Office, Excel, e-mail and internet function