QA Specialist – Newbridge
Cpl in partnership with our client Pfizer are currently recruiting for a QA Specialist in their Newbridge site. This is an exciting opportunity to join Europe's largest manufacturers of solid dose pharmaceuticals.
Role has responsibility for carrying out tasks pertaining to compliance and product quality. Providing Quality oversight and ensuring compliance with regulatory requirements (GMP & controlled substances). This role is required to partner with relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. This can include but is not limited to batch disposition, documentation management and approval, product record review, investigations, complaints, change control, audits, quality agreements, stability, QA support for validation activities, supplier management and regulatory support.
- Ensure strict adherence to site policies/procedures, cGMP 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 and reported on time.
- Provide subject matter expertise and support for systems, technologies and products.
- Identify Continuous Improvement opportunities and progress Continuous Improvement projects.
- Participate in decision making in consultation with relevant stakeholders
- Support the introduction of new products.
- Authors, tracks, review for adequacy and/or ensure timely closure of commitments (Regulatory Agency, investigation, audit, PRR, and other).
- General support of the Quality Systems and compliance monitoring through the following; internal and external audits and dealing with queries from other functions.
- Compilation and approval of relevant PRR sections (where required)
- Trend reviews and SQRT (Site Quality Review Team) updates (where required)
- Training for system users / participants
- Area/departmental weekly/monthly reporting.
Specific areas of responsibility
- Manage and maintain the Documentation System
- Site contact for live documents within the Documentation Management System
- Act as an approver of documents in the Documentation Management System where required
- Management of site archive, storage, retrieval and destruction processes
- Generation of Site Audit schedule in line with corporate and regulatory requirements (including controlled substances) and applying risk based approach
- Review and approve internal audit reports
- Conduct audits as per internal audit schedule
- Conduct Supplier audits as required
- Actively participate in preparation for and management of 3rd party, MSQA and BOH inspections as part of site audit team.
- Identify and communicate to site management on internal audits trends identified and recommendations for areas of focus / actions required
Audit Quality Agreements
- Ensure Quality Agreements are in place with all 3rd parties, affiliates and other Wyeth/Pfizer sites as required by Chapter 7 of EU Volume IV and corporate standards
- Conduct periodic reviews of all Quality Agreement
- Liaise with other sites/centre functions for relevant Quality Agreements
- Provides QA guidance to the manufacturing/packaging /Laboratory and assists with the identification and investigation of QAR’s/LIR’s.
- Initiates, authors, and assists in approvals of QAR’s, LIR’s & VIR’s ensuring they contain the essential elements necessary for maintaining product compliance and continuous improvement in PPU performance. Assures completeness in terms of root cause, action taken, and CAPA.
- Co-ordinate and Assist with the analysis and investigation of customer complaints
- Uitilise both Corporate and local systems for management, investigation and reporting of customer complaints
- Ensure all complaints are closed within specified timeframes
- Trending & Reporting of Customer Complaints
Document Initiation, Review and Approval, Product Registrations
- Preparation of and QA review and approval of documentation as required by procedures.
Review / Approval of Batch-related documentation
- Provides Quality oversight for the generation and approval of all batch documentation relating to processing/packaging activities including Master BMRs, Master Packaging Records, Cleaning Records, Bulk Specifications, Recipes, Packaging Specifications, Batch related reports etc
Product Records Review (PRR)
- Work with areas / subject matter experts to ensure timely evaluation and completion of PRR chapters and compilation of final report.
- Facilitate creating and maintaining the schedule for completion of PRR’s
- Liaise with subject matter experts and system owners in order to collate product specific information for the PRR chapter reports
- Review, compile and maintain all procedures and supporting documentation associated with the PRR process
- Ensure agreed commitments are entered onto commitment tracking system and tracked and trended
- Track and report on the completion status of sub-element reports
- Facilitate creating the schedule for Annual Stability Programme
- Ensuring Annual Stability Programme is maintained and executed to plan
- Initiates, authors or assists in out of specification investigations
- Key role in participating in Stability Review Board process
- Participate in forums required to support the operation of Quality Systems / Process
- Provision of an efficient, customer focused service to the PPU
Raw Material Compliance & Packaging Component Quality
- Raw Material Compliance (e.g. Raw Material Certification)
- Ensure site BSE/TSE status is maintained current (co-ordinate review and generation of JUs, RA’s and PRAs)
- Oversight of raw material vendor investigations.
- Approval of GMP documentation in support of raw material testing
- Approval of vendor investigations
Supplier Quality Management
- Co-ordination of the Supplier Quality Management process including
- Preparation of Supplier Quality Agreements in conjunction with supplier quality management teams
- Liaising with business and purchasing as part of the supplier sourcing and assessment process
- Preparation / approval of supplier qualification packs
- Maintenance of supplier status on SMS
- Monitoring / reporting on supplier qualification metrics to meet re-evaluation requirements, including escalation of supplier quality issues / adverse audit findings
- Liaising with corporate to meet all requirements for Legacy plans / ongoing system maintenance
- Assist in the generation of the Supplier Audit schedule.
Packaging and Bulk Batch File Review / product disposition
- Review of batch files for disposition of product by a Qualified Person.
- Works with site QPs to ensure timely review and issue resolution of completed batch files
- The maintenance of current work instructions and procedures for tasks within job purpose and breadth.
- Ensures compliant dispositioned batches and performs tasks to achieve same.
Product Regulatory Compliance (CNM)
- Responsible for working with Quality on site & the GCMC organization in ensuring Marketing Authorisation (MA) Compliance for products released from the Newbridge site.
- Provide Technical direction & guidance on regulatory impact of changes introduced on site through the site’s change management process.
- Co-ordination of BOH requests, commitments and declarations.
- Co-ordination of site documentation to support regulatory filing activities
Minimum Qualification Requirements
- Third level qualification /degree in a science/technical field is preferred. Exceptions may be considered where relevant experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
- 2 years previous Pharma industry experience in a similar role (research and/or industry) is preferred.
- Experience in dealing with Regulatory compliance desired.