Assistant Manager
Assistant Manager
Posted on :
20-04-2025
Employer Active
1 Vacancy
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Job Description
Masters (Pharmaceutical Chemistry / Organic Chemistry/ Quality Assurance) with 10 14 years experience in APIQA.
Roles and Responsibilities
- Prepare and Review Standard Operating Procedures and Guidelines for DQA.
- Review documents with respect to drug substance such as protocols SOPs test methods data BMR BPR ROAs COAs and reports through collaboration with PRD ARD and QC scientists to achieve the highest quality from technical and compliance perspectives.
- Review process development documents including KSM/KRM identification specification proposal analytical method development/validation reports stability protocols & reports and safety studies.
- Responsible for investigations against laboratory Incidents OOS OOT encountered with aim of root cause identification and CAPA implementation.
- Responsible for assessing the impact review and closure of Change control requests and Deviations.
- Responsible for CAPA implementations verification of and effectiveness.
- Responsible for maintaining the Quality Metrics and preparation of Quality Metrics.
- Plan execute internal audits external audits and communicate audit schedules outcomes to audit stakeholders ensuring CAPA appropriateness for closure audit trending for continual quality improvement.
- Review and approval of Stability management activities of Drug substance and Drug products such as Stability Protocol data and stability summary report.
Competencies:
- Presentation &Communication Skills
- Excel Skills
- Interpersonal Skills
- Team Player
- Negotiation Skills
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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