Senior Manager

1 week ago

Goa, India Unichem Laboratories Limited Full time
Responsibilities

  • Review Out of specifications (OOS), Out of trend (OOT), Out of Calibrations (OOC) and Laboratory Incident investigations and guide the team in handling such situations in scientific manner which includes thorough investigations and appropriate CAPA.
  • Audit external testing laboratories including the quality control laboratories of various manufacturing plants and draw appropriate conclusions.
  • Handle computerized system validations.
  • Handle various quality management systems like change controls, deviations, quality risk assessments pertaining to quality control laboratory.
  • Understand and perform analytical method validations, analytical method verifications and analytical method transfers as per various regulatory requirements.
  • Handle various regulatory inspections like USFDA, MHRA, EMA, PICS, ANVISA, SAPHRA, etc.
  • Review electronic data and audit trail of various analytical instruments.
  • Understand and handle various highend instruments like HPLC, GC, Malvern Particle Size analyzer, FTIR, UV Visible spectrophotometer, Dissolution tester, Disintegration tester, Autotitrator, LCMS/MS, GCMS/MS, ICPMS, PXRD.
  • Conduct training on various aspects of quality control operations and its compliance, computerized system validations.
  • Perform qualification of various analytical instruments in the laboratory.
  • Review of data backup and restoration.
  • Review of elemental impurity risk assessment and Nitrosamine impurity risk assessment.
  • Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system.
  • Organize and execute internal audits at all plants and corporate departments as per the annual planner.
  • Ensure compliance with cGMP, cGLP requirements and good documentation practices.
  • Review and approve SOP as relevant.
  • Ensure that all team members are trained and updated in line with regulatory requirements.
Desired Skills

  • Should have adequate knowledge and experience in handling Quality Control Operations with ability to Guide the team on various troubleshooting in reputed pharmaceutical organization.
  • Must have experience in regulatory inspections like USFDA, MHRA, EMA, PICS, ANVISA, SAPHRA, etc.
  • Excellent knowledge and hands on experience in CSV, audits, and handling instruments like HPLC, GC, Malvern Particle Size analyzer, FTIR, UV Visible spectrophotometer, Dissolution tester, Disintegration tester, Autotitrator, LCMS/MS, GCMS/MS, ICPMS, PXRD etc.
  • Knowledge on Microbiology will be an added advantage.
  • Proactive approach to internal and external queries.
  • Managing multiple stakeholders.
  • Should hold high standards of business ethics.
  • Excellent eye for detail, communication skills and decisionmaking skills.

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