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.

　　Data and Documentation Specialist

　　To write high quality analytical documentation and to perform analytical data review and data interpretation activities in an efficient and effective manner, in full compliance with relevant documented procedures and pertinent regulatory/company requirements to generate trending and PQR data for Analytical Services.

　　Main Responsibilities:

　　To perform laboratory data review and interpretation in support of ongoing data trending and maintain and review data trending records on a routine basis.

　　To determine and champion best practice for the department in the areas of data generation, documentation and review to maintain regulatory and industry best practice.

　　To assist in the generation of PQR data on a routine basis based on stability and release data generated within the department and to generate the appropriate reports to document this in conjunction with QA.

　　To assist in the preparation and review of technical documentation within the department, as required.

　　To train other members of staff within the department, as required.

　　To ensure that all work carried out complies with departmental procedures and is cGMP compliant.

　　To review analytical and laboratory data for accuracy, completeness and in compliance with documented procedures.

　　To assist in statistical analysis of analytical data to support deviation and OOS investigations.

　　To perform data administration tasks, as required.

　　To track and trend team metrics, as required.

　　To communicate effectively with others on site and to assist with departmental and site wide problem solving as required.

　　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.

　　To maintain a thorough understanding of international regulatory requirements pertinent to the team, and to ensure that all work within the team complies with these, with departmental procedures and the principles of Good Manufacturing Practice.

　　To ensure Compliance Wire is kept up to date.

　　General:

　　The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.GMP Requirements Hierarchy:

　　GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)Qualifications:

　　Minimum of A-Level in Mathematics and/or a scientific subject (preferably Chemist) or relevant long-term experience in a similar role.Experience:

　　Demonstrable previous experience within a similar role.

　　Adequate relevant experience in a regulated environment.

　　Experience of using documentation and data management systems.

　　Good technical writing skills.

　　Experience in use of Microsoft Office.

　　Experienced in using statistical software, ideally Minitab.

　　Basic understanding of Pharmaceutical processes relating to Analytical QC Release & Stability for clinical and commercial supply.

　　Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

　　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.

　　Why work for PCI Pharma Services?

　　At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

　　PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled