QA Specialist

This Medical Device Manufacturing Client is looking for a Quality Specialist with 'batch release' experience to work at their Farnham site, although a perm role (with benefits) for 12 months, it could be extended due to circumstances.

For this role, you would report to the QA Manager on site, and liaise with several other departments and Client sites.

For this role you must have:

* Working in a GMP environment making pharmaceutical products

* QA batch release experience

* Pharmaceutical quality system experience

The primary responsibility of the role is to perform key quality activities relating to batch manufacturing documentation, customer complaint management and to support the Quality Assurance Function with overseeing the core quality system processes, therefore ensuring that quality standards and business needs are met at the site in Farnham.

Responsibilities

· To coordinate and maintain all activities required for the disposition of finished product by Qualified Persons. This includes partnering closely with manufacturing / operations team; diligent review of batch records for pharmaceutical drug products.

· To review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of finished product by Qualified Persons.

· Liaise with external contractors and third-party service providers regarding the review and approval of quality documentation.

· Support in the supplier qualification, review and management processes as necessary as well as maintenance of the Approved Supplier List (ASL)

· Prepare any required corrective and preventative actions related to the release of finished product.

· To conduct reviews of artwork and label approval process for manufactured product.

· To support the release, shipment, quarantine and rejection procedures for drug finished product.

· Support the product recall procedure and escalation process.

· Support in the generation of APQR reports and communication with relevant SMEs.

· To support customer enquiries and complaints procedure with the support of Quality Leads.

· Participate in the internal audit programme and ensure timely completion of audits.

· Track Key Performance Indicators for the quality system processes. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training.

· Provide input into the key quality processes of customer complaints, deviations, CAPA’s and change controls, assisting in root cause analysis, prompt responses/ resolution and ongoing data evaluation to ensure any emerging trends are acted on with the support of Quality Leads. Focus on Continuous Improvement opportunities.

· Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review meetings and Annual Product Quality Reviews.

· Assist in the management of the SVMP to ensure adherence to the schedule and departmental objectives.

· Assist in the generation, review or approval of other technical documents i.e. batch documentation and job plans.

Skills and Attributes

Demonstrated advanced computer skills – Microsoft Office preferred.

Excellent verbal, written and interpersonal skills.

Demonstrated success working in a team environment.

Competent, highly organised individual who pays strict attention to detail.

Ability to work in partnership with personnel in the Site Functional teams, other sites and customers.

Education and Experience

Educated to degree level or equivalent in an appropriate scientific discipline such as Chemistry, Biochemistry, Microbiology, Pharmacy or Life Sciences.

Educational background should be supported by proven experience in an appropriate Quality role within the Pharmaceutical, Biotechnology or Medical Device industry.

Demonstrated knowledge of Quality Management Systems and relevant standards (GMP, ISO, ICH, CFR etc.) within the medical device and/or pharmaceutical industry