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.

　　Primary Responsibilities:

　　Compliance review of batch documentation.

　　Perform a batch file review for batches manufactured/packed at PCI or in third party company.

　　Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.

　　Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers. Review and filing of same.

　　Coordination of every product supply chain flow – products which are coming from rest of the world and releasing to the European Union

　　Preparation of every documentation (MIA licence change / QTA review, / Regulatory Filing review/ Audit reports)

　　Participating on weekly customer meetings – discussion/collection/summary about the necessary quality documentation

　　Based on the customer forecast – batch record review- sterile/non-sterile – bulk and finished product. Justify that product is in full compliance with GMP and regulatory filing.

　　Writing SOPs or Work Instructions

　　Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.

　　To liaise with Customers / suppliers for artwork related queries and management of approval of artwork.

　　Ensure activities observed are in compliance with the requirements of cGMP.

　　Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings.

　　Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

　　Secondary Responsibilities

　　Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

　　Requirements:

　　Degree and/or relevant experience

　　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