Collins McNicholas

Providing Quality oversight for Tech Transfer Projects to ensure compliance with regulatory and cGMP requirements during the design, qualification and operational readiness phases for a number of site critical projects. 

Job Responsibilities: 

• To provide consultative support on quality related issues to project teams. 
• Participate in cross-functional teams as required. 
• Ensuring all production steps have been performed and verified, that all limits and specifications have been met. 
• QA support for qualification activities – review and approve equipment/utility qualification documentation from design to post-execution. 
• Review/approval of technical documentation. 
• Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production, 
• Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required. 
• Participate in the internal audit programme as required. 
• Maintain tracking system for project document review status. 
• Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies. 
• Co-ordinate and review change controls as required. 
• Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition. 
• Review of regulatory documentation 
• Assist in the creation and maintenance of up to date QA policies, SOP’s and reports. 
• Assist in the development of training curricula and records for the QA Operations Group. 
• Perform and assist with additional duties as may be directed by the QA Ops Lead. 

5. Education/Experience 

• B.Sc. degree in biology, chemistry, or another related technical degree. 
• Min 4 years working experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role. 
• Previous QC/QA and/or pharmaceutical experience in a GMP or GLP facility. 
• Excellent communication and interpersonal skills. 
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Apply for this job
  • Find a job
  • Apply
  • Get a job