Qualified Person

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.

We are looking for a Qualified Person to join our clinical team. (Hybrid/remote)

Overall Quality Responsibilities

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• The Qualified Person is responsible for certifying investigational medicinal products in accordance with requirements of Protocol, Investigational Medicinal Product Dossier (IMPD) and Product specification File (PSF)
• The compliance of all certified batches to EU Directives, Annex 16 and Annex 13 / Detailed Commission Guidelines where applicable for Investigational Medicinal Products (IMPs).
• Provide the Quality management team direct support and guidance in all quality matters as directed by Head of Quality to ensure that Quality operations meet the requisite 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 Declaration to declare product manufactured in accordance with both trial-specific processes as well as EU GMP standards.
• Support in QP certification of Biologics (DS/DP) sterile, solid dose to finished packed Investigational medicinal products, including ATMP certification.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

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.
• Realise “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
• Provide audit support as required for client Health Authority Inspections, internal auditing program and supplier audits. Ensuring any observations are adequately and promptly addressed.
• Provide support to Customer complaints and deviations and join cross functional resolution initiative.
• Join Mock recall teams to ensure adequate and responsive recall processes are intact for customer equivalent actions

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 organisation and 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.

Knowledge / Skills & Experience

Essential:

• 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.
• Steriles experience is desirable but not essential.
• Sound industry knowledge of the requirements of EU GMP.
• Extensive quality systems and quality operations experience.
• Strong organisational / time management skills. Effective interpersonal communications, leadership and man-management 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.

Desirable:

• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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.