Reporting to the QA Team Leader, a contract position has arisen within the Quality Assurance Department in Pfizer's API site in Ringaskiddy. The QA Specialist will be committed to continuous improvement, leading initiatives and working with members of the Value Stream, Operations, Engineering, Supply Chain and Quality Operations to assure high quality standards that support the Ringaskiddy site strategy.
Areas of responsibility may include:
1. Compliance with ICHQ7 and Pfizer requirements
- Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
- Disposition of intermediates and API including batch record review.
- Review and approval of deviations, change controls, SOPs, out of compliances, laboratory investigations and Post MIs.
- Lead /support process, equipment and cleaning validation.
- Ensure all quality systems are implemented/executed in compliance with ICH Q7 and PQS.
- Lead periodic audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements.
- Maintain internal audit schedule.
- Compilation of weekly quality metrics.
- Assist with regulatory inspections.
- Assist with the development and delivery of cGMP training.
- Review and Approval of Project and Equipment Qualification Documentation.
- Revising SOPs and providing training as SME where required.
- Ensuring that the Quality Assurance SOP periodic review schedule is maintained.
- Maintenance of the Annual Product Review schedule and assist in the preparation of annual product reviews.
- Present at SQRT meetings as required on selected quality systems.
2. Quality Culture / CI: Develop and promote a strong quality culture focussed on RFT, CI and individual accountability
- Lead/support root cause analysis investigations including Pfizer Human Performance (PHP) investigations and quality risk assessments to ensure effective investigations to identify and implement CAPAs within the agreed timeframe
- Execute/support projects to drive quality excellence (using benchmarking as required)
- Lead/ support site projects as required
- Work within a process Team/Value stream centered organization in order to achieve high levels of performance and continuous improvement
- Support internal audit program and weekly walk through audits.
3. Batch release (supply): Responsible for batch release lead time enabling on time production and shipping
- Enable release adherence to the planned production and shipping schedule
- Deliver on target batch review times
4. Safety: responsible for initiating and investigating SII and completion of safety actions
The successful candidate should have:
- BSc in Chemistry or equivalent.
- Thorough knowledge of GMP’s and regulatory expectations for manufacturing of APIs
- Relevant years of experience working in the pharmaceutical manufacturing industry, preferably in Quality or a related Technical function.
- The ideal candidate will be a self-starter with the ability to work on their own initiative and within teams.
- Strong communication and organizational skills are important with the ability to build relationships internally and externally
- Excellent ability to deliver results, with strong interpersonal and influencing skills.