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Roles and Responsibilities
We are looking candidate for QA role for Dehradun Location.
Responsibilities :
1. Ensuring preparation and compliance for various cGMP monitoring and regulatory, customer as well as internal Quality Audit/Self Inspection
2. Ensuring document control by designing, monitoring compliance of system for document control-distribution, retrieval and archival of documents.
3. Monitoring of product technology transfer to site, and decision for batch planning as per Validation Master Plan.
4. Accountable for Batch release/rejects.
5. Responsible for overall Quality Assurance functions at site.
6. To participate in design, develop, implement and monitoring of quality system by design required for manufacturing and testing of pharmaceutical drug product as per cGMP at site.
7. To ensure compliance of procedures related to cGMP are followed for storage of starting material, processing and testing of intermediates and finished product at site.
8. Responsible for approval of batch records, COA and subsequent approval and rejection of starting materials and finished product.
9. To review and approve quality related documents like SOPs, Site Master File, Validation Master Plan, Product Quality Review, Process validation protocols and reports, Cleaning validation protocols and reports , Analytical method protocols and reports and other validation documents and reports.
Qualification :
B.Pharma
QA Head
cGMP
Quality Assurance
Skills highlighted with ‘‘ are preferred keyskills
Company Profile
