Quality Assurance Lead

5 months ago

Hay, United Kingdom PCI Pharma Services Full time

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.

Purpose

To ensure that all Commercial/Clinical packaging is in compliance with regulatory processes/processes for licensed product/Clinical Processes. Manage the daily activities of the Quality Assurance Officers.

**Responsibilities**:
- The support and maintenance of the company’s quality programme as defined in the Quality Manual and Site Master File.- Assist training needs of the Quality Assurance Officers - performing training as and when appropriate and maintain the training matrix.- Set and track objectives given to the team throughout the time period involved, conducting and carrying out performance appraisals/ documented 1:1s. Support with absence management and recruitment.- Support Manage and prioritise the QA Officer workload.- Attending appropriate meetings (daily/weekly/monthly internal & external customer meetings; new product introduction/project kick-offs) with both internal & external customers.- Support with management of non-conformances raised within the Quality Management System (QMS). Review and assess events initiated, ensuring that all events are classified correctly in terms of risk and have been raised in conjunction with procedure. Determine next steps for event (ie raise to Non Conformance or Deviation).- Review and approval of deviation reports ensuring that root cause analysis has been completed and robust actions have been identified to eradicate reoccurrence of an issue. Assist with product impact assessments.- Communicate non-conformances with clients. Work with clients to request investigations for client non-conformances, close out when investigation complete. Send internal Events / Deviations reports to clients in conjunction with the Quality Technical Agreement requirement. Seek approval where required.- Analyse, trend & recommend continuous improvement solutions to data gathered and presented within the company’s daily/weekly/monthly Key Performance Indicator’s (KPI’s). Ensure that the Quality metrics including Right First Time (RFT), Event / Deviation, Corrective and Preventative Actions (CAPA) closure & any other relevant Quality metrics are maintained to the expected levels.- Gather, present and improve KPI’s with customers relating to commercial/clinical activities through continuous monitoring at regular calls and business review meetings.- Acting as the customer’s representative as and when appropriate on all matters pertaining to the quality of the company’s commercial and clinical operations, provide feedback to internal representatives and work with the Customer Services team to enhance the customers experience.-
- Approval of manufacturing, packaging records (BPR’s) related to production activities. Approval of master BPR’S/Pre Machine Trials and validation documents. Authorisation of Artwork, Specifications and print mats.- Generate/assist of Quality Technical Agreements pertaining to customer related activities.- Generate / assist with generation of Clinical Declarations and Qualified Person (QP) to QP agreements.- Assist with serialisation quality related issues.- To assess, generate, maintain then implement quality related Standard Operating Procedures (SOP’s) and training guides relating to the quality technical roles. Support with approvals of documents in the PQMS.- Conducting internal Internal auditing to confirm compliance to EU Good Manufacturing Practice (GMP) and adherence to company procedure and policy.- Assist in hosting customer/regulatory audits as and when required.- Use Lean principles and relate these to improving efficiencies within the QMS/quality departments.- Ensure all quality related and personnel issues are reported to the QA Manager in a timely way or escalation to Senior Quality Management team if required.- Ensure adherence to Health and Safety requirements within the team and ensuring adherence to safe working practices across the site at all times.

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._

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