Description: PE Global is recruiting for a QA Manufacturing Compliance Specialist on behalf of a leading pharmaceutical company in Sligo. This is an initial 12-month contract role.
Responsibilities:
* Ensure products leaving meet standards for marketed and investigational drug products.
* Ensure products and aseptic process simulations manufactured meet requirements of end users, regulatory authorities, and the company.
* Provide quality and compliance oversight and assistance to Operations function to manufacture products in compliance with site policies and procedures.
* Provide quality oversight during aseptic processing of products, including aseptic intervention observation.
* Lead/assist in investigations arising out of product or manufacturing processes non-compliance.
* Review/Audit completed Batch Records.
* Review Manufacturing Logs as required.
* Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
* Complete Line Clearance activities.
* Complete Incoming Raw Material checks, including product status maintenance.
* Provide Stability Program Support, sample pulls, weekly checks, protocol generation.
* Finished product status maintenance, including labelling.
* Administer Quality Logs, QA Hold, Sample Request.
* Lead operations floor daily walk around of manufacturing areas.
* Drive continuous improvements and simplify site processes and procedure to ensure compliance at all times.
* Other support as deemed necessary.
Education and Experience:
* Third level degree in science, quality, or engineering discipline.
* Ideally previous experience in quality role.
* A minimum of three years' experience in quality/operations role in highly regulated GMP environment. Biologics manufacturing experience desirable.
* Experience in aseptic processing gained within quality or operations role desirable.
* Strong knowledge of regulatory requirements required.