QA Manufacturing Compliance Specialist
Orion Group Life Sciences is recruiting a QA Manufacturing Compliance Specialist on behalf of a Multinational Biopharmaceutical client based in Sligo, Ireland.
This is an initial 12-month contract with the potential to extend.
Key Responsibilities:
* Providing quality and compliance oversight and assistance to the Operations function to manufacture products in compliance with all site policies and procedures.
* Aseptic/sterile filling experience using isolator technology/open fill line technology and single-use assemblies.
* Batch record review and assisting in investigations.
* Leading/Assisting in investigations arising out of product or manufacturing processes non-compliance.
* Review/Audit of completed Batch Records.
* Review of Manufacturing Logs as required.
* Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
* Completion of Line Clearance activities.
* Completion of Incoming Raw Material checks, including product status maintenance (as required).
* Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
* Finished product status maintenance, including labelling as required.
* Administration of Quality Logs, e.g. QA Hold, Sample Request.
Requirements:
* Third-level degree in a science, quality, or engineering discipline.
* Ideal previous experience in a quality role.
* A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment.
* Experience in biologics manufacturing is highly desirable.
* Experience in aseptic processing gained within either a quality or operations role is highly desirable.
Cognitive Skills:
* A high level of attention to detail and mental concentration.
* Proven problem-solving skills and the ability to adapt to new requirements.
* Innovative thinking.
* Results-driven.
* Total commitment to quality and maintaining a high standard of work.
* The highest levels of integrity and a strong work ethic.
Estimated Salary:
+60,000 - +80,000 per annum, depending on experience.