QA Associate - Biopharma

Competitive
Contract
Cork
07 Feb 2020
BBBH752923

Bio-pharmaceutical site in Cork is looking for an experienced Quality Specialist to join their team

Overview:

I am currently working with a bio company in Cork who are looking for an experience quality specialist to join their team. This company puts the patient at the heart of everything they do, and they strive to provide innovative therapeutics to patients with serious unmet medical needs.

This role (the Quality Assurance Associate) will report to the Quality Assurance Team Lead in the drug substance manufacturing part of the business, and is responsible for supporting site quality systems, manufacturing operations, site start-up and inspection readiness.

Reviewing and approving of deviations, change controls, process changes and batch records will be a key element to this role as will approval of validation protocols. Supporting cross functional GMP readiness initiatives, audits and releasing of Raw materials will also be critical elements to the role. Close working relationships in relation to H&S, capital projects, lot releases and the manufacturing teams on site will call for someone who is an excellent communicator and someone who is not afraid to integrate with site teams.

Education & Experience:

  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • Minimum 3 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.
  • Experience in supporting manufacturing operations and batch record review is highly desirable
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.

This is a 12 month contract role with possibilities of extension. This is also a shift role where there is a 6 week shift cycle as follows: 1 week or earlies (6.30am - 2.30pm), 1 week of lates (2.30pm - 10.30pm & 4 weeks of days (8.30am - 5pm). There will be a shift premium for the early and late shifts.

If this role is of interest to you, don't hesitate to reach out by clicking the 'Apply Now' or by calling 021 2300 300 to discuss in more detail.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Similar Jobs

Junior level QA opportunity: Ideal for a candidate located in Mid/ West Cork or East Kerry
Cork06.04.2020
Excellent Associate Scientist role with a global biotech based in Cork
Cork25.03.2020
Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.com