QA Specialist Quality Systems
Cpl, in partnership with our client Pfizer are currently recruiting for QA Specialist Quality Systems:
Job Purpose:
To partner with other Pfizer Functional area personnel to ensure that all batches are manufactured and tested to cGMP requirements in the Grange Castle Facility and to support the disposition of production batches.
To provide QA support to the Quality Control team and their customers on laboratory related Investigations and other aspects of Quality Systems including regulatory compliance, technical, systems and reporting.
Responsible for Quality Systems Programs e.g. APQR, PQS, Compendial Affairs, Change controls, BCRB, Market Action as assigned.
Ensuring global quality system requirements are in place, monitored and reported out on.
Reporting Structure:
Quality Site Leader
⇧
Quality Assurance Manager
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Quality Assurance Quality Systems Lead
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QA Specialist
Job Responsibilities:
- Liaise with Corporate SMEs and cross functional site teams to enhance the site Quality Systems programs from a compliance and efficiency standpoint.
- Take ownership for the Quality System processes and procedures, including Compendial affairs, Deviation Management, Change Control Program, PQS, APQR, Site Trending Program, BPDR, Market Action. Lead/attend the associated forums.
- Support trending and compilation of quarterly investigation/ system reports and audit listings in a timely manner. Present out on adherence to Quality Systems site metrics.
- Represent the QA team at senior management team meetings.
- Assist in the generation and maintenance of Quality procedures and reports.
- Responsible for writing, review and approval of investigations, change controls, commitments in the QTS system, ensuring records are generated in compliance with relevant guidelines.
- Responsible for performing Pfizer Human Performance interviews and Method 1 ‘s arising from investigations.
- Partner closely with customers and stakeholders to understand and deliver on all records within timelines and escalate when necessary.
- Participate in cross functional teams as required. To provide consultative support on quality related issues.
- Participate in the audit program as required and carry out cGMP compliance area walkthroughs as applicable ensuring site is always audit ready.
- Co-ordinate and participate in the change control/ BCRB process for products manufactured across the various Pfizer sites.
- Participate in and support IMEX processes (Visual Management, Standard Work, CI).
- Ensure that GC Quality systems are always inspection ready.
- Perform and assist in additional duties as directed by the Quality System Lead.
People / Values
• Demonstrate the Pfizer values
• Adhere to all HR Policies as appropriate
• CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
• Proactive and positive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive & effective communication within and across shifts
Education/Experience:
- Relevant Third Level Qualification or Equivalent
- Previous relevant Quality experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company.
- Exceptions may be considered where relevant skill/ experience and attitude and behaviours exist (this may be supplemented by further education).