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Specialist - QA Ops - Manufacturing Mgmt

Salary undisclosed

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Job Description Summary This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are driven in alignment to site objective/s.Job DescriptionKey Responsibilities:
  • Ensure all activities in compliance with cGxP, incl. data integrity
  • Review and approval of analytical data / tests (analytical release)
  • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
  • Support exception investigations
  • Review and approval of production, QC, and AS & T records
  • MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
  • Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions
  • Participate in HSE risk assessments. Preparation and participation to internal HSE audits
Role Requirements :Essential Requirements:
  • 3+ years of experience in pharmaceutical quality control, quality assurance or production
  • Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
  • Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
  • MS Office applications and other standard IT applications supporting Quality activities
  • Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
Desirable Requirements:
  • University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
Skills Desired Continued Learning, Gmp Procedures, Managing Ambiguity, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence
Job Description Summary This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are driven in alignment to site objective/s.Job DescriptionKey Responsibilities:
  • Ensure all activities in compliance with cGxP, incl. data integrity
  • Review and approval of analytical data / tests (analytical release)
  • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
  • Support exception investigations
  • Review and approval of production, QC, and AS & T records
  • MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
  • Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions
  • Participate in HSE risk assessments. Preparation and participation to internal HSE audits
Role Requirements :Essential Requirements:
  • 3+ years of experience in pharmaceutical quality control, quality assurance or production
  • Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
  • Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
  • MS Office applications and other standard IT applications supporting Quality activities
  • Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
Desirable Requirements:
  • University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
Skills Desired Continued Learning, Gmp Procedures, Managing Ambiguity, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence