Position: Quality Operation Manager (Karachi)
Job Specification
Qualification: B Pharm / Pharm D plus Degree in Management Sciences (MBA)
Experience: Minimum 5 years in a managerial position within an MNC or national pharmaceutical company
Job Description
- Supervise administrative activities of chemical & microbiological sections for raw material & finished product analysis & testing.
- Authorize release or rejection of incoming supplies, raw materials, or finished products.
- Oversee in-process testing of manufactured items.
- Review final microbial test reports.
- Monitor environmental conditions & advise on corrective actions in sterile areas.
- Follow up on development & evaluation of analytical methods & stability studies.
- Write/rewrite specifications, test methods, & other QC procedures including SOPs as necessary.
- Handle technical problems related to quality control.
- Ensure maintenance of department premises & equipment.
- Ensure validation processes, including analytical procedures & calibration of equipment, are completed.
- Manage availability of chemicals & glassware, and monitor personnel responsible for these tasks.
- Coordinate training programs for QC personnel.
- Ensure operational status of QC lab equipment & adequate space; liaise with service engineers for maintenance.
- Plan QC testing schedules in coordination with production planning.
- Participate in business/technical review meetings and implement action points.
- Manage administrative activities within the Quality Assurance section.
- Supervise release of finished products for the market.
- Handle customer complaints.
- Supervise vendor audits, internal audits, and facilitate customer audits.
- Oversee retention of reference samples & batch dossiers as per regulations.
- Supervise in-process checks during manufacturing.
- Perform any other duties assigned by superiors.