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Job

Quality Assurance Specialist

  • Location

    Berkshire, UK

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    £45,000 - £50,000

  • Contact:

    James Brookes

  • Contact email:

    j.brookes@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    6 months ago

  • Expiry date:

    2019-05-11

  • Startdate:

    ASAP

A fast-growing rare diseases pharma company is looking for a QA Specialist to join their team on a permanent basis.

The company is at an exciting stage and major phase of growth with a multiple of products in the process of being launched out to the market.

Key responsibilities:

  • Provide QA support for the manufacture of products.
  • To ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements.
  • Participate in the appropriate project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
  • Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs) so that roles and responsibilities between the contracted parties are clearly defined and implemented
  • Ensure that an appropriate level of product batch record reviews are carried out at partner sites.
  • Regularly review non-conformances e.g. process deviations, out of specification/trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s), that suitable reports have been written and that corrective and preventative actions (CAPAs) have been implemented within suitable time periods.
  • Participate in the internal audit (self-inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department

 

To be considered for this role you need 3+ years’ experience in GMP QA and experience of working in an aseptic or biologics environment.

 

Any questions don’t hesitate to get in touch!