05 Nov
|
Walter Bushnell
|
Roorkee
05 Nov
Walter Bushnell
Roorkee
- Department: Quality Assurance
- Area: AQA
- Designation: Senior Officer / Executive
- Qualification: B. Pharm / M.Sc. / M. Pharm
- Work Experience: 2-4 years / 5-7 years
Key Roles &
- Responsibilities
1. Contract Analytical Laboratories: Qualification, compliance review, and surveillance auditing.
2. Component &
- Material Disposition: Reviewing analytical records to approve/reject starting, in-process, and finished materials.
- Procedure Approvals: Verification of SOPs, Batch Records (MBR/BPR), and validation protocols.
- Product Release Authorization: Ensuring strict compliance of production and laboratory records before distribution.
- Investigation Management: Handling deviations, laboratory incidents, OOS, and OOT.
- Complaints &
- CAPA:
Directing complaint investigations and assessing corrective/preventive actions.
- Regulatory Liaison: Coordinating notifications, Field Alert Reports (FARs), and action plans.
- GMP/GLP Standards: Establishing validation, stability, and operational SOP guidelines.
- Auditing &
- Compliance: Conducting internal self-inspections and external vendor audits.
- Risk Management: Executing Quality Risk Management procedures.
- Comprehensive Training: Administering technical, analytical, behavioral, and GMP calendars.
📌 Hiring For AQA | OSD Formulation | Roorkee
🏢 Walter Bushnell
📍 Roorkee