Job ref: PDFG011026Job type: PermanentLocation: NewryClosing date: Thursday 15 Oct 2026 17:00
Main Activities/Tasks
- Ensure operation of labs is in a controlled, predictable and compliant manner at all times
- Planning & execution of weekly schedule
- Oversight of all Finished Goods outputs across multiple sites
- Maximise laboratory capacity – people & product
- Drive efficiencies to enhance productivity
- Ensure alignment of QC and production schedules
- Consolidation of documentation & processes across Finished Goods laboratories to optimise performance
- Align with Customer Services and Production Planning to deliver appropriate schedules to meet Customer due dates
- Develop & deliver KPIs to track lab performance against targets
- Work with other Leads to identify synergies and maximise performance – including people, processes, equipment, budget/consumables
- Drive performance ensuring QC laboratories are enablers to Customer delivery performance
- Implement and enforce the company’s EHS policies and procedures, creating a culture and environment where these become an integral part of each employee’s behaviours and by this means ensure a high level of compliance.
- Report to the Leadership Team and QC Director on key EHS KPIs and status of action plans.
- Ensure that task-based risk assessments are available for all activities performed within the QC laboratories.
- Ensure that all QC Finished Goods teams operate in full compliance with all GMP and regulatory requirements.
- Drive simplification and cost saving initiatives across all finished goods teams.
- Ensure that the QC Finished Goods department is audit ready at all times, reviewing, closing and tending observations from internal audits / audit readiness inspections and taking action to correct root causes and prevent reoccurrence.
- Have oversight of / set expectations for people management:
- Setting department and personal goals.
- Managing team and individual performance.
- Managing staffing and absenteeism.
Essential Criteria:
- 10+ years of experience in a GMP pharmaceutical laboratory
- 5+ years of experience in a leadership role.
- Degree or equivalent in an area of pharmaceutical sciences (Chemistry, Biochemistry etc)
- Thorough understanding of cGMP and regulatory requirements and guidelines (VMD, CVM, FDA, ICH, ALCOA+)
- Expertise in out of specification (OOS) and out of trend (OOT) investigations
- Expertise in QMS records (Deviations, Change Controls, CAPA management and Complaints)
- Expertise in Stability Programs
Desirable Criteria:
- Previous experience working within a QC finished goods department
- Active participation and engagement in regulatory inspections such as VMD, FDA and HPRA.
- Ability to develop and write standard operating procedures.
- Strong knowledge of finished product dose forms and analytical testing techniques (HPLC, UPLC, GC, Dissolution, Viscometry, UV and IC)
- Experience in method validation, verification and method transfers.
- Experience in setting and tracking and managing key performance indicators (KPIs).
- Experience in driving continuous improvement in areas of health and safety, productivity and output or compliance.
Benefits:
- Free life assurance
- Pension salary sacrifice scheme with 5% employer contribution
- Healthcare cash plan
- 32 days annual leave (increasing with length of service)
- Wedding leave
- Enhanced Maternity / Paternity Pay
- Company Sick Pay
- Subsidised Canteen Facilities
- FREE On-site parking
- Cycle to Work Scheme
- Tech Purchase Scheme
- Free Will-Writing Service
- Employee perks/discounts scheme
- Employee Assistance Programme (EAP)
- Employee well-being initiatives
- Employee recognition scheme
- Career development opportunities
To Apply Please forward your CV via the APPLY Now button below.
WHJS1_NI
…
