Purpose of the Position/ Role Summary
Reporting to the Site Director of Quality, the QA Analyst ensures that products manufactured, tested, released and distributed via Contract Manufacturing Organisations (CMOs) and contract laboratories comply with cGMP/GDP, Marketing Authorisations and Bimeda standards. The role leads QA oversight of external partners (CMOs/3PLs/contract labs), approves key quality documentation (e.g., deviations, change controls, CAPAs, validation), manages complaints and product quality reviews, and supports artwork control, stability, EM and recall readiness. The role also provides training and coaching on documentation and cGMP expectations and 
supports audits/inspections.

Key Role Specific Requirements

CMO & Contract Partner Quality Oversight
• Coordinate recurring CMO meetings and quality business reviews covering performance metrics, complaints, deviations, CAPAs, change controls and commitments.
• Review/approve CMO Validation Protocols/Reports and Sampling Plans; ensure statistically justified approaches (e.g., ANSI/ASQ).
• Lead/participate in CMO audits and Contract Lab Qualification; track and verify completion of CMO CAPAs and follow-up actions.
• Maintain Supply Chain Maps for CMOs and ensure GDP compliance across logistics partners; support 
qualification/oversight of 3PL and Contract Lab Testing.
• Coordinate and approve QC Method Transfers to CMOs; ensure data integrity, comparability protocols, acceptance criteria and transfer reports.

Quality Management System (QMS) Ownership
• Maintain and update the Quality Manual/SMF; ensure alignment with licences and BAHL procedures.
• Administer/approve Change Controls, Deviation/LIR, CAPA, Documentation Approvals, Documentation Reconciliation, and Archiving for CMO batches and records.
• Plan and execute Internal Audits; collate outcomes into Management Review; track QMS KPIs and continuous 
improvement initiatives.
• Oversee Calibration Programme from a QA standpoint and support QC Equipment Transfers lifecycle controls. 
• Issue, reconcile and archive Logbooks in accordance with data integrity expectations.

Product Lifecycle & Technical Activities
• QA review/approval of CMO Validation Protocol Approvals / Validation Report Approvals; ensure protocol-to-report 
traceability.
• Establish and oversee Stability Programme Testing (protocols, pulls, investigations, reporting, commitments).
• Administer EM Programme (Environmental Monitoring) data review/trending (as applicable for retained BAHL facilities or lab partners).
• Coordinate Finished Product Testing and Raw Material Testing via contract labs/CMOs in line with specifications and release requirements.
• Maintain BAHL Artwork process and CMO Artwork approval, ensuring change control integration.
Complaints, Deviations & Investigations
• Lead Customer and Supplier Complaints investigations, including root cause analysis, risk assessment and CAPA 
effectiveness checks.
• Oversee CMO Deviations and internal Deviation records; ensure timely closure and product impact assessment.
• Manage RM/FP Rejections (Raw Material/Finished Product) and ensure appropriate disposition and escalation.
• Compile and present BAHL CMO Summary PQR, CMO PQR and BAHL PQR; ensure annual product quality review 
completion and action tracking.

Regulatory Interface & Recall Readiness
• Support the BAHL Responsible Person (GDP) and Regulatory Affairs on HPRA and other HA notifications (e.g., quality 
defect/recall, significant changes, licence variations, CMO/3PL changes).
• Maintain Recall readiness (mock recalls, distribution traceability, retained samples) and coordinate with partners to 
execute when required.
• Coordinate Licence Variations quality inputs (validation impacts, stability commitments, artwork updates, SMF updates).
• Inform HPRA (how/when): collaborate with RA to determine the correct notification/variation route and timing; notify when we are closing it down (e.g., site testing/distribution cessation) per regulatory guidance and BAHL procedures.

Samples, Records & Archiving
• Own the Reference and Retain Samples programme: define storage locations/conditions, chain of custody, retention 
periods and retrieval; ensure alignment with MA/HPRA expectations and BAHL SOPs.
• Oversee Archiving Documentation for CMOs and contract labs to ensure complete product histories and 
inspection-readiness.

Training & SOP System
• Maintain and author SOPs, CMO Questionnaires, and related controlled documents; ensure version control and training 
assignment.
• Deliver QA Training (data integrity, documentation, investigations, change control); track effectiveness.
• Provide inputs to Management Review on QMS performance and training compliance. 

Meetings, Reviews & Cross-Functional Collaboration
• Lead routine CMO Meetings and cross-functional forums; capture minutes, actions and decisions.
• Prepare quality inputs and actions for HA Audits and customer inspections; coordinate responses and CAPA tracking

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Other Requirements

Essential:

BSc in a science or related field.
• Knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry.
• High integrity; excellent attention to detail; analytical thinker; organised; team-oriented; self-starter.
• 2–3 years relevant experience in a regulated pharmaceutical environment (QA/QC).

Desirable:
• Experience with external manufacturing/CMO oversight and contract lab management. 
• Familiarity with HPRA, EU GMP/GDP, and product lifecycle documentation (SMF, PQR). 
• Working knowledge of sampling standards (e.g., ANSI/ASQ), stability/IQ-OQ-PQ, and data integrity (ALCOA+). 
• Strong communication skills to manage partner relationships and drive timely closure of quality actions