TGR_Stability Coordinator

PCI Pharma Services; Tredegar; On-site; GBP 30,000 - 50,000; Full time

Job summary

Join a forward-thinking company dedicated to life-changing therapies, where you will lead stability studies and ensure compliance with regulatory standards. This role offers the opportunity to manage stability projects, generate technical documentation, and train team members in a collaborative environment. You will play a crucial part in bridging the gap between innovative therapies and patients, while continuously improving processes and systems. If you are passionate about making a difference and thrive in a dynamic setting, this is the perfect opportunity for you to grow your career.

Qualifications

• Proven experience in managing stability studies and ensuring quality standards.
• Strong understanding of regulatory and ISO requirements.

Responsibilities

• Lead and manage stability studies within Analytical Services.
• Generate and authorize technical documentation for stability testing.
• Train team members on stability management systems.

Skills

Stability Study Management

Regulatory Compliance

Technical Documentation

Project Management

Training and Development

ISO Requirements Knowledge

Education

Degree in Life Sciences or related field

Tools

Stability Management Systems

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main purpose of role:

1. To organise and manage all stability studies within the Analytical Services department.

2. To ensure compliance with relevant Company, local and international Regulatory and Client requirements at all times.

3. To ensure that stability time points and sample pulls comply with relevant procedures and Client expectations and data is reported in line with Technical Agreements, Internal procedures and client expectations.

4. Responsible for leadership of the stability study management within Analytical Services Group ensuring timely co-ordination of routine stability analysis, with respect to set down and pull dates in line with business needs.

Main responsibilities:

Technical/Analytical Services

1. To lead and drive the management of stability studies within Analytical Services to achieve the required business standards in terms of quality, safety, KPI’s, etc.

2. To maintain stability inventory and facilities.

3. To generate and authorise technical documentation (inc. stability protocols and stability reports) and to routinely participate in review procedures in relation to stability testing activities. This may extend to other areas within the Department, as required.

4. To prepare technical documentation within the Department, as required.

5. To train others as required, to ensure that all members of the Team are adequately trained in the use and running of the stability management systems.

6. To maintain a thorough understanding of international regulatory and ISO requirements pertinent to the role and to ensure that this information is made available to the team, with departmental procedures and the principles of Good Manufacturing Practice.

7. To ensure that all stability study co-ordination activities including those of sub-contract facilities providing a service to the Team and co-ordination team investigations, deviations and change controls are complied with, subject to there being no attenuating circumstances.

8. To carry out and manage projects within the Department and at international level, as required.

9. Review and improve on stability management systems in line with business needs.

10. To communicate effectively with other groups on site and external clients and to participate with them in problem solving activities as required.

Continuous Improvement

1. Review and improve departmental processes and eliminate waste.

General/Other duties

1. To identify self-development needs for future performance.

2. To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.