LSC have a great contract opportunity for a QA Validation Associate to join a Cork based Biopharmaceutical company.
If you have 3+ years of experience within a GMP environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide quality oversight for validation activities related to products and facilities, utilities, equipment (FUE).
- Support the development of validation plans for specific system implementation projects.
- Supporting and reviewing/approving (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
- Support validation policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
- Lead and represent QA Validation in multi-departmental meetings & project teams.
- Participation in the change control program for modifications to qualified systems.
- Quality oversight for the Revalidation Evaluation program.
- Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- 3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
- Organizational and management skills to coordinate multi-discipline project groups.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Kathy Gillen at LSC on 021-4777329 if you have any more questions about this opportunity!
