
Manager / Senior Manager Quality Control
3 days ago
RESPONSIBILITIES
- Daily planning of analytical activities, resource management and work allocation.
- Plan and execute sampling and analysis for raw materials, packaging materials, intermediates & finished products.
- Review and /or Approval & Implementation of Standard operating procedure
- Review and /or Approval of Implementation analytical protocol and analytical reports
- Review and /or Approval of Qualification and calibration of Instruments.
- Investigating and review of Investigation related to Laboratory Events, OOS, OOT and Deviations.
- To ensure the QC related electronic data management compliance such as computer system validation, electronic data backup, storage and retrieval.
- Conduct induction training, on-thejob, annual training and analyst qualification to enhance analytical skills of quality control personnel.
- Procurement and inventory control of material and equipment required for QC activities.
- Review analytical activities related to process validation, cleaning validation and analytical method validation.
- Authorise to release of raw material, intermediate, stability samples and working standards in absence of QC Head through LIMS.
- Monitoring of non-routine Activities like stability study, working standard Management, calibration Management, Analytical Method Transfer / method Verification.
- Responsible person for all QC activities in absence of Head – QC.
KEY SKILLS and COMPETENCIES
- Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc.
- Adequate experience of auditing finished dose formulation units, API and Intermediate/KSM vendors.
- Experience of working in API unit would be preferred.
- Very good functional knowledge and application.
- Proactive approach to internal and external queries.
- Managing multiple stakeholders.
- Should hold high standards of business ethics.
- Excellent communication skills and decision-making skills.
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