PE Global are currently recruiting for a Quality Operations Quality Specialist on behalf of our client based in Dublin:
11 Month initial contract – This role will be a 12/4 shift role. 4 consecutive. 4 12 hr shifts followed by 4 days off rolling
This facility will be a significant supplier of drug substances for one of client’s key treatments and will also be critical in the future supply of new biotechnology products to its global network.
POSITION RESPONSIBILITIES
With energy and enthusiasm, the Quality Ops Specialist will:
- Support quality aspects of drug substance manufacturing to ensure compliance with company policies, procedures and regulatory expectations.
- Provide Quality oversight to Upstream maufacturing activities on the production floor as part of facility start up and routine manufacturing.
- Review and approval of site operations Standard Operating Procedures (SOPs) and Work Instructions (WI).
- Support electronic batch record review and review of related batch documentation to ensure timely release and disposition of drug substance batches. Review will encompass review of production and equipment logbooks and audit trails.
- Support sustaining activities such as Deviation and Change Management.
- Serve as a quality resource for assessing Quality Risk Assessments
- Use of Quality Risk Management and Operational Excellence to promote continuous improvement.
- Provide quality oversight for engineering changes impacting manufacturing equipment.
REPORTING STRUCTURE
The QA Ops Quality Specialist will report to the Upstream Quality Lead for the Biotech Dublin site.
QUALIFICATIONS & EXPERIENCE – KNOWLEDGE AND SKILLS REQUIREMENTS
- This role requires a minimum of 3 years’ experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
- A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
Technical
- Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
- Experience in batch record review and review of batch related documentation.
- Technical experience in aseptic processing or manufacturing operations.
People
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn, improve and develop
- A great communicator, decisive decision maker and proven ability to deliver excellence
- Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence
- Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Experience with new product introductions and/or process qualification/technology transfer
- Detail oriented and meticulous worker
Education
- Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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