Cpl in partnership with our client, a global pharmaceutical company based in Co. Kildare, are currently recruiting for a QA Support Lead to work on a permanent basis. Our client site is an integral part of its global solid oral dose network; manufacturing tablets and capsules for world markets using leading edge and highly complex manufacturing processes. The site has been an established leader in the supply of medicines for over twenty years and is currently expanding its product portfolio.
The QA Support Lead acts as a role model, coach and mentor for other colleagues both within the QA team and other team’s onsite to advance the ‘Culture of Quality’. The role is self-directed and has responsibilities with respect to providing direction, coordinating, facilitating and undertaking activities pertaining to quality and compliance. The role provides technical expertise with a focus on continuous improvement and right first time. The role also represents the QA u nit by liaising with internal and external customers or serving as a designee for QA Lead. This role may also act in a system specialist capacity, with responsibility for a specific GMP system.
This particular role will have leadership responsibilities for the products manufactured under contract for third parties, aligned with the Pfizer Centre One (PC1) organisation to support existing and new customers for Quality and Regulatory topics.
More broadly the role and others in the peer group are responsible for the following:
QA Support Lead supports the QA Team and Partners with process teams and relevant departments to ensure that key quality systems are operated and maintained in a compliant manner and meet business needs.
Assist and participate in the assurance of QA compliance activities required to ensure that procedures are in accordance with cGMP and corporate policies, standards and values. Ensure continuous communication with relevant departments/functions to facilitate the implementation of plant wide initiatives. Liaising with external bodies (corporate, regulatory agencies, customers, CMOs) as required for the operation of Quality Systems / issue resolution
- Ensure strict adherence to site policies/procedures, cGMP/GLP and environmental, health and safety regulations.
- Ensure area of responsibility is maintained in a constant state of compliance and audit readiness in line with current regulations, PQS, and business needs.
- All related procedures and documentation are maintained accordingly.
- Safety and housekeeping considerations
- Execute responsibilities in line with Right First-Time principles Ensure resolution of and/or appropriate escalation of issues Demonstrating company values and Pfizer competencies
- Ensure that all department metrics are adhered to
- Provide subject matter expertise and support for systems, technologies and products.
- Identify Continuous Improvement opportunities and Network best practices, and progress Continuous Improvement projects.
- Participate in decision making in consultation with relevant stakeholders
- Coaching and development of colleagues & process teams to enhance technical capability and Quality Culture Support the introduction of new products.
More Specific responsibilities include:
- Responsible for review and approval of responses to internal and external audits and regulatory reviews. Responsible for direct interaction with external auditors when required.
- Management of customer audits
- Review and approval of procedures, reports, metrics related to quality systems and PC1 customer products.
- Lead / Participate in forums required to support the operation of Quality Systems / Process and interface with customer requirements
- Conduct internal audits
- Inspection readiness / preparation and Management.
- Lead customer requirements for Quality Agreements, Audits, Complaints, Deviations, Product Quality Reviews, Regulatory Support, Change Management etc
- Liaising with internal and external stakeholders to lead/deliver requirements for Quality related elements (e.g. agreements, investigations, risk assessments, document approval, change control, CAPA) in line with SOPs, relevant Quality Agreements and PC1 processes
- Participating in PC1 and Customer on-site reviews as site QA representative
- Supporting new business sourcing requests through data provision and representing the Quality organisation.
- Batch Review and Certification (where licensed QP)
- Responsible for ensuring appropriate accountability is delegated to key personnel and for implementing appropriate quality risk management tools / decision making.
- Promoting Quality and Compliance expectations and culture across the organization.
- Third level Qualification/degree in a life science/relevant technical discipline.
- Exceptions may be considered where relevant experience and correct attitude and behaviour exist (this may be supplemented by further education in parallel).
- QP Eligible desirable but not limiting
- Minimum of 5 years’ experience in the pharmaceutical industry in the area of Quality Assurance (exceptions may be considered).
- Experience in dealing with Regulatory compliance desired.
- Ability to represent the company in external forums
Please note a valid work permit is required for this position and there is no relocation support available.