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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. • Sampling, approval and release incoming good, packaging materials and product (where required) for use in production. • Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production. • Review and filing of acetates for use in sampling. • Identify training needs and conduct staff training as required. • Maintenance of sampling documentation and retain samples in archive. • Management of the Supplier/Customer Defect (SCD) system. Issue the SCD numbers, coordination of completion of the SCDs with the customer/supplier and close out of the SCD. • To liaise with customers/supplier for artwork related queries and management of approval of artwork. • Review and approval of Master Packaging Material Specifications. • Ensure excellence in Housekeeping. Carry out housekeeping audits and prepare the reports. • Raise and close deviations and Corrective/Preventative actions as required. • Ensure activities observed follow the requirements of cGMP. • Assist in validation studies as required. • Ensure safe work practices are being always followed, report any defects immediately to the Safety Officer and attend Health and 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. • Scan the completed documents into the designated folder and update the Archive list accordingly. Essential: Bachelor’s or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements. 2+ years’ experience working in GMP or Regulated Environment Proven track record of delivering results Ability to work toward clearly defined goals, communicate progress effectively, and meet predefined targets One to two years of experience working in Quality / QA Ability to manage multiple tasks and prioritize effectively based on business needs Strong problem-solving and troubleshooting skills, with a dynamic and proactive approach Self-motivated with a results-driven mindset 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. 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.
Pciservices
IRL_Dundalk, Ireland