Ensure adherence to Regulatory expectations in relation to self-inspection, supplier audits, Pfizer Quality System (PQS) compliance and to support the submission of any requests from Regulatory Agencies. Partner with other Pfizer functional area personnel to embed a strong and sustaining compliance culture. Improve the knowledge, mind-set, and culture of compliance across the site.
- Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.
- Ensure Quality Assurance Auditing policies and procedures are kept up to date and aligned with Pfizer Quality standards and Regulatory requirements.
- Partner closely with customers and stake-holders 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.
- Support all aspects of Quality/GMP compliance across the site from generally improving the knowledge, mind-set, and culture of compliance across the site through the existing OpU Compliance Forums/Inspection Readiness Meetings to embed a strong and sustaining compliance culture.
- Support and participate in site self-inspections, internal audits, board of health audits and third party audits.
- Support management of the supplier audit programme for all materials supplied to Grange Castle and other Pfizer sites, contract laboratories and service providers
- Support the submission of any requests from Regulatory boards of Health’s for new submissions and on-going renewals.
- Author, track, review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc.
- Support inspection readiness activities from initial notification, through to hosting and follow ups for Regulatory inspections.
- Ensure inspection readiness work is completed.
- Carryout cGMP compliance area walk-throughs of Manufacturing and Laboratory Operations as required ensuring site is always inspection/audit ready.
- PQS compliance – provide support to the PQS gap assessment process - timely implementation of changes and remediation activities.
- Support the use of visual management to track and trend activities.
- Perform and assist in additional duties as directed by the Site Compliance Lead.
- To be successful in this role the following are prerequisites to application:
- Hold a B.Sc. degree in biological / chemical Sciences, business, or other related technical degree or equivalent experience in regulated industry. (Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
- Previous relevant Quality experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company.
- Excellent communication and interpersonal skills.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
- Flexibility to travel in support of the role
- Have experience in representing your functional area on a network learn
- This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.