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À propos
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Key Responsibilities
Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
Provides presence on the shop floor to support compliance and data integrity
Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
Participates as the quality member on cross functional projects
Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
Provides support to internal audits and regulatory inspections
Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
Drive continuous improvement and utilise problem solving tools and Production Systems Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
Education and Experience
5 years of relevant post‑degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations. xcfaprz
Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
Understanding of QA operations an advantage as well as Regulatory agency engagement.
Experience working on manufacturing shop floor
Familiarity with GMP documentation review and/or shop floor auditing
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Compétences linguistiques
- English
Avis aux utilisateurs
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