Manager / Senior Manager Quality Control

5 days ago

Pithampur, Madhya Pradesh, India Unichem Laboratories Full time ₹ 1,04,000 - ₹ 1,30,878 per year

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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