Overview
This Medical Device Manufacturing Client is seeking a Quality Specialist with batch release experience to work at their Farnham site. This is a permanent role (with benefits) for 12 months and includes a 10% completion bonus. You would report to the QA Manager on site and liaise with several other departments and client sites.
Responsibilities
* 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.
* 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, CAPAs 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.
Qualifications and Experience
* GMP environment experience applying to pharmaceutical products
* QA batch release experience
* Pharmaceutical quality system experience
* Degree or equivalent in Chemistry, Biochemistry, Microbiology, Pharmacy or Life Sciences
* Proven experience in an appropriate Quality role within the Pharmaceutical, Biotechnology or Medical Device industry
* Knowledge of Quality Management Systems and standards (GMP, ISO, ICH, CFR, etc.) within the medical device/pharmaceutical industry
Skills and Attributes
* Advanced computer skills – Microsoft Office (preferred)
* Excellent verbal, written and interpersonal skills
* Team player with strong collaboration
* Highly organized with strong attention to detail
* Ability to work with site functional teams, other sites and customers
Education and Experience
* Educated to degree level or equivalent in a scientific discipline (Chemistry, Biochemistry, Microbiology, Pharmacy or Life Sciences)
* Proven experience in a Quality role within Pharmaceutical, Biotechnology or Medical Device industry
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Technology, Information and Internet
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