Quality , Science, Pharmaceutical & Food
QA Associate – Cork
PE Global is currently recruiting for a QA Associate, Drug Substance Operations, on behalf of our client based in Cork.
23 month initial contract
Note: Shift role – 6-week cycle including 1 week of earlies and 1 week of lates with 4 weeks of days. Earlies = 06:30am-14:30, lates = 14:30-22:30 (Friday 06:30am-13:30, 13:30-20:30).
QA Associate, Drug Substance Operations
- Provide QA support to the site for drug substance GMP operations (Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, Automation and Process Engineering, MES, QA Validation and Capital Projects)
- Participate within inter-departmental and cross-functional teams to immediately address issues in real time
- Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections
- Review of MES Exceptions
- Support lot release activities/schedule including preparation of BDS/FBDS lot files
- Daily presence and support in the process teams and on the manufacturing floor including walk-through of process issues and RCAR support
- Release of Raw Materials for drug substance production
- Review and approve deviations and QC LIR reports to ensure that root causes have been identified, appropriate corrective actions have been implemented and appropriate impact assessments are complete
- Review and approve Change Control documents pertaining to Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, QC In process/Micro, Automation and Process Engineering, QA Validation, IT/CSV and Capital Projects to ensure changes are appropriately assessed and all required actions are identified and implemented
- Review and approval of process and equipment validation/qualification protocols/reports.
- Review and approval of master batch records on MES
- Write, review and approve SOPs, Work Instructions, Quality Technical Agreements, Specifications, Quality Risk Assessments, PDD, PCRA and other GMP documentation in accordance with Policies. Conduct Periodic Review of QA SOPs
- Review and approval of Supplier Change Notifications
- Assist with preparation of Annual Product Review documents (APRs) and YBPRs (Yearly Biological Product Reports)
- Support cross-training of team members
- Support quality systems on site.
- Support site inspection readiness activities and provide assist with audits and regulatory inspections, as required
- Support and drive Continuous Improvement/Lean initiatives on site
- Compile and present metrics as required
- Other duties as assigned
QUALIFICATIONS & EXPERIENCE – KNOWLEDGE AND SKILLS REQUIREMENTS
- Minimum 3-5 years relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Regulatory Compliance.
- Experience and ability to work cross functionally.
- Demonstrated experience in supporting manufacturing operations, batch record review, MES and deviation/CAPA is highly desirable.
- Experience with batch release activities is an advantage
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
- Ability to coach junior QA staff
- Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
- Education: Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
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 email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***