Reporting to : Incharge -QA
Functions of the Position:
This is a non-supervisory position in DCTI Quality Assurance Department for monitoring the activities in the in the Analytical Services Laboratory and Purification Services Laboratory for compliance to DCTIs Quality Management System, Regulations, applicable guidelines and Customer/ contractual requirements.
- Review of Analytical Method Development, Validation, Verification and Method. Transfer Protocols, Analytical data and reports specifically related to HPLC, GC, LC-MS/MS, GC MS/MS.
- Responsible for compliance monitoring, implementations of DCTIs Quality Management System, Policies, and Procedures in applicable areas.
- Review of Equipment Qualification data and calibration data.
- Responsible for closure of incidents, deviations, OOC, and participate in the investigations and shall ensure effectiveness of CAPA where applicable.
- Follow up audit actions and to verify the CAPA against non-conformity reports raised at previous audits.
- To ensure document control and data integrity in applicable areas.
- Should handle the audits conducted by Regulatory bodies, statutory bodies and Customers.
- Quality Management System Orientation to applicable new joiners.
- Training the applicable department staff on Quality systems, regulations, QA related procedural documents.
- Responsible for ensuring archival and retention of all the documents and records as per the procedure.
- Maintenance of master lists of internal and external documents.
- Review and maintenance of external calibration certificates.
- Review the changes through change controls and implementation.
- Preparing of QA related procedural documents.
- Any major issues related to QMS, cGMP shall be reported to Management.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Professional
Role: Pharmacist/Chemist/Bio Chemist
Employment Type: Permanent Job, Full Time