Microbiology Projects and Validation Lead
- Barnard Castle, County Durham (GBR)
- £15 - £17.5 Per Hour
- 12 Months
- Start date: 15 Mar 21
- Ref: GSK0JP00087693
- gmp
- microbiological
- validation protocols
- quality management
- technical standards
- audits
- compliance
- people management
- risk assessment
- project plans
- resource planning
- pharmacy
- coaching
- mentoring
- npi
Job description
Posted 15 February 2021
Microbiology Projects and Validation Lead
GSK Barnard Castle
12 Month Contract
Pay: up to £17.50/h PAYE
Job Purpose
Directly responsible to the Microbiology Operations manager for management of projects and performance of validation protocols. To ensure all aspects of the operation or projects within the team’s field/s of expertise are performed and to ensure compliance with regulatory and company expectations are maintained. Direct link to the Microbiology technical standards team, and Technical experts.
Responsibilities applicable to all roles at Barnard Castle PSC site:
- To work as a flexible and motivated member of the team.
- To follow all Standard Operating Procedures (SOPs) and/or Standards of Work (SW) applicable and in which the individual has been trained.
- To act at all times in compliance with Good Manufacturing Practices (GMP) and to report any quality issues.
- To act in a safe manner, always (in compliance with the Health & Safety at Work Act, and all other relevant legislation) and to use GSK safety reporting systems to highlight potential hazards.
- To remain up to date with all training requirements (both ‘classroom’ courses and computer- based training through the ‘My Learning’ internal platform).
- To take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes.
- To take part in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
Job Responsibilities:
- Management of project and validation support across capital and NPI projects.
- Ensure provision of resource for BI and thermal mapping activities.
- Provide direct support and management of team to satisfy agreed service levels with the Sterile Business Unit.
- Provide leadership, perform investigations and generated associated documentation within areas of expertise.
- Provide leadership and input to site projects where required, ensuring costings are cross-charged as appropriate.
- Represent the department in communication with external regulatory bodies and facility-based audits.
- Maintain awareness of regulatory requirements, changes in requirements and incorporate as necessary within microbiology. Ensure techniques and practices are maintained in line with current regulatory and industry best practice.
- Ensure methodology is robust, compliant and validated.
- Direct line management of staff, ensuring staff development and performance is optimized by acting as a mentor, assisting with the provision of development plans for relevant staff. Provide coaching in technical and regulatory procedures as required. Ensure staff development and training is optimized and clear objectives are in place.
- Ensure staff have the necessary support required to perform project and NPI activities within the required timescales.
- Provide resource planning related to NPI activities and ensure validation performed to schedule. Escalate resource issues and agree prioritization. Liaise with project planners to ensure all Microbiology activities are included in project plans and provide updates as necessary.
- Ensure all staff can work in a safe environment and any new processes/ products/materials to site are appropriately assessed for safety.
- Work with the Microbiology technical standards lead to ensure all project and validation activities are performed to schedule.
- Work with the micro Technical Standards team and Technical Experts to ensure mentoring in technical and regulatory procedures as required
Minimum Level of Education Required
- HNC/HND in a science or related discipline. (Microbiology, Pharmacy, Chemistry or another related science)
Technical Experience
- In depth knowledge of GMP and Regulatory requirements specifically related to microbiological requirements
- A minimum of 3 years’ experience within a managerial role in Microbiology.
Knowledge
- People Management Project and change management
- Microbiological risk assessment
- Knowledge of Quality Management systems
- External regulatory inspections
- Knowledge of production processes
- Knowledge of laboratory processes
- Validation of microbiological techniques and practices
- Microbiological process validation
