Do you want to work for a leading partner within the pharmaceutical industry that is accredited by over 30 regulatory agencies world-wide and has had 30% growth in the past two years? Would you like the opportunity to work for an industry-leading quality team?
We are looking for an customer-centric, people orientated and innovative individual to join a company who is a international leader for drug development and delivery and has an industry leading quality team and management system. Due to growth and new equipment on site, the company is looking for an established QA Validation Manager who can support and provide a strategic leadership and manage available resources for the design and execution of all site validation activities. Ensuring that the facility remains compliant with its validation commitments, current industry expectations and to develop validation strategies to support facility projects and changes.
Reporting to the Head of Quality Systems, your role will include:
- Ensure all validation programs are designed to achieve right regulatory approval.
- Implement validation systems and validation strategies
- Determine appropriate validation resource requirements around site plans.
- Effectively monitor and communication the validation workload requirements and priorities and communicate the validation projects execution plan to other departments.
- To manage project activities against required delivery timelines and report progress to project leader/stakeholders.
- Provide visibility to the operation on the validated status of product /equipment required for manufacture.
- Establish and maintain the validation master plan for each validation stream.
- Participate in periodic reviews during product life cycle to deepen process performance understanding and drive process improvement.
- Provide oversight and validation expertise during the development of new product and new technologies.
- Represent the validation department in regulatory inspections
- Participate in customer regulatory filling reviews.
Skills and Experience Required:
- Suitable scientific or engineering degree
- Experience of managing a validation department within a regulated environment
- Experience in equipment validation
- Experience of strategic leadership and team development
- Knowledge of electronic quality systems such as TrackWise, Q-Pulse or Valgenesis would be advantageous
- Knowledge of FDA guidance, ICH guidelines, EUGMP, GAMP and/or GEP
- Comfortable presenting to customers or regulators
If interested, please submit your CV and cover letter highlighting your expertise in relation to the role. We will send you a confirmation of acknowledgement, please note feedback can take up to 2 weeks. If you have been selected for an interview the process will be divided into 3 stages.
This is a full-time permanent position, paying up a competitive salary & benefits package. You will be based in the company's UK site in South West of England in Wiltshire. Full details will be provided on application. In addition to a generous basic salary, the company offers the following benefits package:
- Bonus - up to 10%
- Annual holidays
- Share options Scheme
- Private healthcare - Single cover with BUPA
- Childcare benefits