Stability Coordinator - Level 1

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.
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 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. 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 minimal supervision. Significant experience within the pharmaceutical industry. Experience in a similar role would be advantageous.
The role This successful candidate will be responsible for the maintenance and services all equipment and materials involved with however, not limited to heating, lighting, ventilation (HVAC), air-conditioning, electrical distribution, water supply, steam/boiler systems, sanitation, public health, fire protection, safety systems, lifts and escalators as well as all facility and utility related services. Main responsibilities: Undertake the maintenance and repair of plant and/or office facilities and associated utilities at the PCI Tredegar sites. Fully contributing to planned preventative maintenance programs whilst adhering to SOP’s and completing necessary documentation ensuring skilled judgements are made to ensure plant is maintained to optimum level. Monitor performance of critical utilities and process equipment in cGMP environment and perform or arrange necessary repairs, adjustments, calibrations, and preventative maintenance, including maintaining appropriate documentation. Liaise with onsite departments to arrange for planned preventative maintenance / rectification work required for breakdowns. Liaise with third party contractors in order to arrange for planned preventative maintenance / rectification work required for breakdowns and to then ensure the prompt return of associated reports. Without supervision promptly attending Facility / utility breakdowns, practice’s systematic fault diagnosis and repairs in optimum time, ensuring minimum downtime and product loss. To comply with company policies, local, UK and global regulatory requirements including internal and external Health, Safety and Environmental standards at all times whilst completing tasks. Assist with the management of vendors, routine equipment repair and maintenance for site facilities and utilities. Assist in the coordinate equipment requisitions with internal departments for building services requirements and carry out equipment and furniture installations. Assist in ensuring any DR, CCR, and actions are completed within the required timescale. To identify self-development needs for future performance. Provide training, support and direction to trainees / apprentices when required ensuring professional standards of workmanship and competence are achieved. Maintaining close co-operation with all other departments to attain continual improvement in performance and standards of quality and reliability. Assist in the Management of electrical energy consumption using monitoring techniques in line with environmental policy. Dependant on knowledge and expertise, provide support when requested to other areas of the business upon the discretion of their department manager. Maintain a degree of flexible working in order to support the business, when required, on weekends or after hours.
Requirements for the role Previous experience in an Engineering role. Ideally pharmaceutical and/or FMCG manufacturing environment covering mechanical, electrical and utilities. Educated to a minimum of GCSE standard or successfully complete a four-year indentured apprenticeship. Reasonable understanding of Health and Safety issues related to Engineering activities. Understanding of GMP is desirable. Good listening and verbal communication skills. Capacity to interpret and understand Engineering/Technical information. Self-motivated. Team player.
Benefits
At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer: Employer Pension:Secure your future with our employer pension scheme (above statutory pension). Competitive Salaries:We offer competitive salaries that reflect your dedication and contributions. Generous Annual Leave:Enjoy 25 days of annual leave, plus bank holidays. Family Friendly Benefits:Enjoy a range of benefits designed to support your family life. Employee Referral Scheme:Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you! Staff Engagement:We value your dedication with recognition schemes and long-service awards. Health and Well-being:Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary. On-Site Subsidized Canteen. Cycle to Work Scheme. Development Opportunities:Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
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.
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