Bio Products Laboratory (BPL), part of Kedrion, is seeking an experienced Quality Assurance Operations Team Leader to join their Quality department in Elstree, Hertfordshire.
As part of the QA Operations Team, you will oversee all QA activities related to the production and QA review of BPL Products, ensuring compliance with regulatory standards and industry best practices.
Your commitment to maintaining the highest quality standards and building strong relationships across the organisation will be key to success in this customer-facing role.
This role is on a 24/7 shift (Monday to Sunday, 7am to 7pm and 7pm to 7am (4 days on, 4 off, 4 nights on, 4 off)
Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.
Duties & Responsibilities:
- Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Quality, GXP and EHS.
- Be responsible for closing out major and minor deviation records and leading major quality investigations where applicable.
- Maintain an ongoing dialogue with Quality Operations Management to ensure quality target and objectives are able to meet business priorities.
- Manage the Quality Management System including oversight of TW records.
- Ensure customer complaints, Deviations, CAPA are completed and progress in a timely manner on the Quality Management System.
- Identify and implement Quality System improvements where necessary
- Lead a team of QA officers in the completion of their day to day activities, ensuring objectives, targets and workloads are achieved and distributed within the team appropriately.
- Support the BPL Manufacturing departments in handling deviations, CAPA and quality incidents.
- Provide support and advice to internal departments to maintain and, where required, improve compliance to quality standards and processes.
- Perform regular trend analysis of deviations, CAPA reviews and customer complaints to identify trends and suggest improvement strategies where required.
- Highlight risk to product quality, patient safety and/or data integrity throughout the quality life cycle so that they are understood, transparent and can be managed through the application of quality risk management approach.
- Deputise for the QA operations manager where required
- Assist and lead in internal audits as part of the self-inspection programme and assist where necessary hosting regulatory audits on site.
- Identify skills and competency development needs within the team. Support individual team development through the training and coaching processes.
- Review and communicate key performance indicators for the team and implement actions to improve these where necessary.
- Support Quality Operations Management in the identification, recruitment and on-boarding of employees into the organisation
- Ensure that the performance of your direct reports meet the standards (competence and behaviours) required by BPL.
- Escalation to the Quality Operations management, at the earliest opportunity, when issues or obstacles that impact on compliance or on time delivery.
- All other tasks as duties, as necessary, to maintain the effectiveness of the Quality Operations activities as required by the business and/or Quality management.
Skills & experience to help you within the role –
Education:
- Degree level qualification, in science discipline or equivalent
Skills and Experience:
- Significant experience of working within an operational quality role, ideally within a bio pharmaceutical, clean room or manufacturing environment
- Knowledge of sterile aseptic filling and packing manufacturing processes
- The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise.
- Experience of leading a team and managing others with the ability to share knowledge, and develop other both within the quality team and in other departments.
- Experience with working with documentation and quality management systems
- Significant risk management experience
- Experience and knowledge in statistical analysis
- A natural tendency towards continuous improvement is required.
In return we offer -
We're looking for highly motivated and experienced people to drive the business forward. In return you'll be supported in developing your skills with ongoing training and career opportunities.
- Competitive salary
- Bonus
- 25 days holiday
- Pension
- Life insurance
- On-site parking
- Employee assistance programme
- My Healthy Advantage phone app
- Virtual GP
- Cycle to work scheme
- Subsided canteen
BPL is based in Borehamwood, in a secure campus surrounded by natural beauty, greenery, lakes and wildlife. To be part of our brilliant team, please apply today.
Please apply today for immediate consideration.