Sector: Life Sciences
Consultant: Stewart McGrath
Salary: £45000 - £55000
Job Status: Permanent / Full Time
Leadership/ People Management: Optimize performance outcomes of direct reports and ensuring individual’s understanding of contribution. Acts as a role model for leadership capabilities and sets the standard to follow
- To lead, manage and develop operators using appraisal, communication and HR systems. Ensure pharmaceutical awareness and operating standards within the team as well as job skills and knowledge.
- Ensure Performance Development Plans are in place for all team members, including both job technical knowledge and pharmaceutical knowledge development.
- Deputise for Production Manager
- Support associated areas when the business requires
- Issue resolution plans utilising Production, Quality and Maintenance resource allocated to the production area with no impact to the schedule.
- Track and monitor downtime in the area, implement strategies to reduce downtime
- Allocation of labour allocation (suitably qualified and experienced) and organisation (to ensure continuous line running where appropriate).
GMP/ Compliance and Ethical Conduct: Ensure compliance of self and others to internal and external regulations. Comply with all systems, processes and procedures in line with statutory/ legislative/ quality requirements
- Deliver a timely closure of BMRs as agreed with the department manager (including all MRP transactions).
- Investigate and lead process related deviations to ensure manufacturing, filling and packaging activities are compliant with cGMP.
- Drive timely completion of DRs, CAPAs, and CCs as agreed with the department manager.
- Drive effective corrective and preventative actions for GMP incidents, troubleshooting situations.
- Identify staff training and development needs to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives.
- Ensure your area is audit ready at all times.
- Through a presence in the workplace, coach and mentor staff to ensure products are manufactured and documentation completed in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.
- Timely completion of relevant deviation and complaint investigations to identify true root cause. Along with timely closure of corrective/preventative actions for deviations, complaints and GMP audits that are assigned to them with a focus on improved processes, documentation, documentation completion and training.
- To ensure work centre and designated areas housekeeping standards are maintained to ensure compliance with Current Good Manufacturing Practice (cGMP) and Health Safety & Environment regulatory requirements by utilizing 5S and lean initiatives
- Completion of Level 1 & 2 audits.
- Maintain a high level of tidiness and cleanliness at all times – personal, personnel, work area and department.
- Ensure aseptic licences, as required, are kept up to date for all personnel involved in sterile manufacturing.
Lean & Change Management: Ensure all work is performed and delivered in accordance to approved and established processes and procedures and proactively look for opportunities to drive continuous improvement, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
- Agree measures of performance and targets with Production Manager, communicate to the teams through the daily communication processes (handovers, huddles and VMBs) to achieve targets.
- Monitor and report team performance to targets using VMBs Tools.
- Develop VMB tools for the area to improve and track KPIs as follows:
- Deliver 100% Schedule Adherence
- Deliver 100% RFT BMR to QA within 24hours
- Deliver OTIF closure rate of all quality actions
- Deliver >95% multi-skilled team – demonstration of cross functional working teams ( manufacturing, filling, inspection, packing)
- Deliver > 50% reduction in Human error DRs
- Zero Critical audit observations
- Zero overdue, CAPAs, DRs, EHS and CCs
- Zero overdue EHS actions
- Responsible for initiating, developing and implementing strategic development programmes relating to improvements and advancement in manufacture, filling, inspection and packing.
- Support the implementation of continuous improvement programmes.
- Support the introduction of new products, equipment and processes.
Safety, Health & Environment: Promote an environment of safety and wellbeing of self, others and environment.
- Understand and ensure implementation of emergency procedures and safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
- Working alongside the EHS Manager and conduct scheduled audits.
- Experience of startup facility activities desirable, good knowledge of facility validation requirements.
- Experience of of Spray Drying systems, bulk powder manufacturing and filling experience.
- Experience of medium to large scale pharmaceutical manufacturing, desirable powder manufacturing.
- Preferably qualified to degree level in Science, Business or Engineering or equivalents.
- Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.
- 5 years’ experience of manufacturing sterile drug products to EU and US standards.
- 5 years leadership experience in a Pharmaceutical environment (Manufacturing, Packaging/ Quality, Engineering or equivalent).
- Experienced in managing and leading change, continuous improvements.
- Understanding of the end to end pharmaceutical manufacturing process essential.
- Aptitude for or working knowledge of mechanical and software operations desirable.
- Demonstrable ability to make sound risk based decisions in line with internal and external quality standards.
- Strong experience in lean manufacturing techniques.