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. Summary Of Role This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP. Part of the Batch File Review Team who: Compile batch documents Review batch documents in advance of QP review Work with responsible site to complete corrections Prepare COC for QP Work closely with QP as issues arise and find resolution 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 API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same. Coordination of every product supply chain flow – products which are coming from rest of the world and releasing to the European Union Participating customer meetings – discussion/collection/summary about the necessary quality documentation Writing SOPs or Work Instructions Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release. Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department. Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company. Essential Knowledge / Skills & Experience Degree and/or relevant experience. GMP experience Steriles Experience Good communication skills. Ability to problem solve. Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets. Minimum 2 yrs years’ experience working in Quality Assurance Proven track record of showing how results were delivered through management/leadership of others. Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets. 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.

As part of the Batch File Review Team at PCI, your role will involve compiling and reviewing batch documents across various process types such as OSD, Sterile, Biologics, Cell Therapy, and Gene Therapy. You will work closely with internal and external stakeholders, preparing documentation for Quality Person (QP) review, coordinating corrections, and ensuring compliance with regulatory requirements. This position offers a diverse range of responsibilities and serves as an ideal foundation for those considering a future career as a QP. Key Responsibilities: - Compile and review batch documents, ensuring accuracy and completeness prior to QP review. - Collaborate with site personnel to address any required corrections and prepare Certificates of Compliance (COC) for QP approval. - Conduct batch file reviews for products manufactured/packed at PCI or third-party facilities. - Raise and report deviations, corrective actions, and non-conformance issues promptly, ensuring timely resolution. - Request and review Certificates of Analysis/Conformance for API/Drug Substance, Bulk Product, and Packaging records. - Coordinate product supply chain activities, including imports and exports to the European Union. - Participate in customer meetings to discuss and summarize necessary quality documentation. - Develop and update Standard Operating Procedures (SOPs) and work instructions as needed. - Maintain batch documents and retain samples in the archive room, updating the Product Quality Review (PQR) database post-QP release. - Ensure adherence to safe work practices and report any incidents to the Environmental Health and Safety (EHS) Department. - Perform additional tasks as required to support the company's overall objectives. Essential Requirements: - Degree and/or relevant experience in a related field. - Previous experience with Good Manufacturing Practices (GMP) and Sterile manufacturing. - Strong communication skills and ability to problem-solve effectively. - Minimum of 2 years of experience in Quality Assurance roles. - Demonstrated track record of achieving results through leadership and management. - Proven ability to set and achieve clear goals within defined timelines. Join us at PCI and play a vital role in bridging life-changing therapies to patients. Let's shape the future together. Equal Employment Opportunity (EEO) Statement: PCI is committed to fostering an inclusive workplace environment that upholds the values of equity and inclusion. We strive to create a culture of understanding, respect, and equal opportunity for all individuals at every level of the organization. By continuously assessing our practices, policies, and programs, we aim to build a community where everyone feels a sense of belonging and can thrive.,

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. PCI JOB DESCRIPTION Job Title: JD-066 Quality Division / Section Qualified Person (Hybrid – 3rd Party Products) Department: Clinical Services Accountable To Associate Director of Quality Accountable for: (People Manager) Yes – includes managerial support to QA specialists Responsibilities Overall Quality Responsibilities The Qualified Person is responsible for certifying investigational medicinal products in accordance with requirements of Investigational Medicinal Product Dossier (IMPD), Product specification File (PSF). The compliance of all batches to EU Directives, Annex 16 and Detailed Commission Guidelines where applicable for Investigational Medicinal Products (IMPs). Provide the Quality management team direct support and guidance in all quality matters to ensure that Quality operations meet the required site safety, quality, and cGMP requirements. Participate in cross functional teams to provide consultative support on quality related issues. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs). During review, the QP ensures that all regulatory requirements are met regarding importation, testing and the release of clinical product to third party sites. Completion of QP Declarations to declare product manufactured in accordance with both trial-specific processes as well as EU GMP standards. Complete the QP review/disposition of Drug Substance/ Drug Product and Finished Pack product of Biologics, Steriles, ATMP’s, across a range of dosage forms e.g Parenteral, Topical, Inhalational, Rectal, Opthalmic. Quality Operations Review batch documentation to ensure that the entire process has been performed in accordance with relevant product specification file (PSF), and cGMP/cGCP, and that it meets customer and agency audit standards. Review of clinical Batch records, including control reports, in-process test reports and release reports demonstrating compliance with the product specification file, the order, protocol, and randomization code Disposition (back to customer QPs or clinical trial site) and certify completed batches efficiently. Achieve “right first time” objectives, tracking quality and efficiency standards. By direct observation and intervention, monitor the application of quality standards to enable quality processes, compliant documentation, timely corrective action and continuous improvement. Quality Systems Provide support with investigations and resolution of discrepancies within deviations. Participating in cross functional teams as Quality/Qualified Person representative Lead or provide CAPA recommendations. Support to change control impact assessments and completion. Communicating with contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and Completion of third-party contractor and supplier quality agreements and supply chain documents. Provide audit support as required for client Health Authority Inspections, internal auditing, supplier audits. Ensuring any observations are adequately and promptly addressed. Provide experienced support to Customer complaints and deviations and join cross functional resolution initiative. Quality Projects and Continuous Quality Improvement Provide support to direct QA reports, in development, progress and feedback. Give quality direction and guidance for projects related to processes, product and compliance Compile new and update existing technical agreements. Support the Quality team in implementation of new product introductions. Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice Develop and sustain an environment of continuous improvement through active implementation of process excellence and lean six-sigma methodologies. Actively promote best practice in quality methods and drive continuous improvement initiatives to improve quality, cost and cycle times. Develop training programs and support in training rollout. General Collaboration across the organisation and act as SME/team representation on required meetings. Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice. Research, analyse and extrapolate critical regulatory information Knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use and the Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014 Knowledge on quality systems regulations, QA principles and industry best practices and standards and utilize in day-to-day activities. Secondary Responsibilities Provide supervisory support to QA specialists and complete review and feedback on batch record review. Support in mentorship capacity. Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company. Requirements Bachelor’s degree in science, engineering, technology or a related discipline. Qualified Person status or eligibility for QP status. Clinical Experience desirable but not essential. At least 3-5 years’ experience in a quality management role in the Pharma industry. Sound industry knowledge of the requirements of EU GMP, steriles experience is desirable. Extensive quality systems and quality operations experience. Strong organisational / time management skills. Effective interpersonal communications, leadership and excellent decision making skills. Experience of working at management level within a similar environment. High motivation, flexibility and the ability to work under pressure and on own initiative. All employees are required to satisfactorily perform the essential duties and responsibilities of their position. The essential duties and responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills required. 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.