Temporary QA Specialist, Operations and Compliance
Vertex Pharmaceuticals Incorporated
London, UK
3d ago

Job Description

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES Key Leadership Skills :

  • Cross- functional collaborator
  • Results DriverKey Knowledge / Skills and Competencies : oAbility to perform functions in accordance with cGMP guidelines.
  • oStrong written and oral communication skills requiredoGood interpersonal skills requiredoAbility to work effectively and meet challenging timelines in a fast paced and high throughput environmentoStrong organizational skills, work ethics and respect for all customers.

    oCollaboration / Teamwork / Conflict ManagementoAbility to independently coordinate with cross-functional teamsoCritical ThinkingoAbility to think strategically and tactically, balancing these as workload changes.

    oFlexibility / AdaptabilityoShould be flexible to work 2nd shift as per the business needsoKnowledge in the following areas : oExpert knowledge of global GMP requirements governing oral drug products and knowledge of oraldrug product manufacturing practicesoProven experience supporting GMP manufacturing either via experience in manufacturing and / or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical roleKEY RESPONSIBILITIES :

  • As part of the Quality Operations and Compliance group primarily responsible with providing quality oversight and support to operations at the Vertex Drug Product Facility (VMC) in the following key areas / activities;
  • support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.

    Product Release Internal Manufacturing

  • Responsible for reviewing batch data, including batch records, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
  • Responsible for archival of batch records and other supporting documents in QDoCCs.Compliance Oversight of Internal Operations QA Operations and Compliance
  • Responsible for raw material release and labelling
  • Responsible for CNC area clearance and equipment release to support manufacturing operations.Compliance Oversight of Quality Systems
  • Responsible for updating QA database based on the ongoing / upcoming clinical and commercial manufacturing.
  • Responsible for generating performance metrics, trends; including site metrics for investigation / CAPA, etc. (as applicable)
  • Responsible for identifying risks and communicating gaps for GMP process / systems.
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area / equipment release, material disposition, quality systems etc.Audit / Inspection Support
  • Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary).REQUIRED EDUCATION AND EXPERIENCE :
  • Demonstrated success by independently collaborating with cross-functional teams
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting : ocGMP’s and associated CMC regulatory considerationsoexperience with continuous manufacturing a plus
  • Experience with network based applications such as Oracle and TrackWise preferred.
  • B.S in scientific or allied health field (or equivalent degree) with at least 5 years of relevant work experience
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