Senior Executive - Manufacturing Compliance
STRIDES PHARMA GLOBAL PTE. LIMITED
SG, Jurong, Tuas, SG
23h ago
source : GrabJobs

Responsibilities

  • Ensure Good Manufacturing Practices in manufacturing and warehouse area.
  • Review and identify areas of improvement in the manufacturing and warehouse.
  • Ensure all instruments / equipment’s and associated software’s are meets the 21 CFR-Part11 compliance.
  • Review audit trail verification / Alarm history of all instruments / Equipment’s in production for accuracy, correctness and completeness.
  • Ensure critical control points are followed during drug product manufacturing.
  • Review of investigations associated with batch processing.
  • Ensure online / Good Documentation Practices.
  • Ensure manufacturing and warehouse areas are up-to-date and ready to face audits any time.
  • Support the Manufacturing and warehouse for up-keeping of facility / systems / procedures / documentation etc.
  • Review and ensure all the instruments / Equipment’s are qualified as per the current practice.
  • Ensure the CSV done as per the current regulatory requirement.
  • Review and harmonize the procedures.
  • Requirement and Key competencies

  • Education Level Degree holder in Pharmacy, Life Science or Engineering
  • Minimum 5 years relevant experience with pharmaceutical companies and preferably in a Quality function.
  • Strong GMP experience : Having already participated and managed audits of external agencies (USFDA, MHRA etc)
  • People management : leadership, cooperative, ability to influence
  • Excellent critical thinking and problem solving capabilities
  • Teamwork, influencing, communication skills, negotiation, conflict management
  • Effective problem analysis and problem-solving
  • Results oriented, Self-starter and hands on.
  • Documented on judgment decision-making ability
  • Meticulous and always challenge status quo
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