Executive / Senior Executive / Assistant Manager QA

2 - 7 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Veko Care Private Limited

time outline icon Pune, Maharashtra, India

Posted on 09-08-2021

94 Views

1 Vacancy

Description

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 authorize 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.
Review and approval of APQR of Oral dosage and External preparation.
Handling Item code generation of RM, PM & FP and maintain master list.
Batch number allocation to new products.
Technology Transfer report review and approval.