Stability Coordinator

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

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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.

The role

The purpose of the role is to organise and manage all stability studies within the Analytical Services department and 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 expectation.

This role is also 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:
- 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.- To maintain stability inventory and facilities.- To generate and authorise technical documentation (including stability protocols and stability reports) and to routinely participate in review procedures in relation to stability testing activities.- To prepare technical documentation within the department, as required.- 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.- 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 GMP.-
- To carry out and manage projects within the department and at international level, as required.- Review and improve on stability management systems in line with business needs.- To communicate effectively with other groups on site and external clients and to participate with them in problem solving activities as required.- Review and improve departmental processes and eliminate waste.- To identify self-development needs for future performance.- 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.

Qualifications and Skills- Minimum Degree in a Scientific Subject (preferably Chemistry or Microbiology).- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.- GMP Requirements Hierarchy and GMP Skill Level 1 is essential for this role.- Requirements Hierarchy can be obtained at SOP-L&D-001).- Excellent IT skills.- Ability to manage changing priorities under mínimal supervision.- Significant experience within the pharmaceutical industry.- Experience in a similar role would be advantageous.

Join us and be part of building the bridge between life changing therapies and patients.

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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._