Vivid Resourcing Ltd Kent, UK
Responsibilities: Responsible for managing all quality aspects of external contractor activities and/or oversee GMP work placed with the contractor. Ensure regular communication with contract manufacturers' quality unit, and manufacturing/packaging/distribution/IGOT personnel to foster strong working relationship. Engage the contract vendor in the resolution of their investigations, deviations, change control or out of specification results. May lead or support internal investigations and complaints of varying complexity regarding quality and/or regulatory events Responsible for regular communication of quality status Maintain the QA vendor management quality system for assigned vendor(s), ensuring maintenance of quality agreement. Manage audit and re-audit status for contract vendors as applicable. Monitor and report vendor quality system performance and risk rating plans to compliance forums, vendor quality councils and leadership. Establish, implement and report annual quality site visit and quality review meeting plans define and manage CAPA and mitigation plans. Identify possible quality continuous improvement plan Lead or contribute to initiatives relating to technical/quality process improvements through collaboration. Liaise with other Quality Assurance Vendor leads to review shared trends and overall quality oversight alignment. Provide support to external audits and regulatory inspection outcomes to determine Pfizer impact. Provide support to internal audits (eg R&D Oversight (CRC RDO) group, MSQA) & regulatory Inspections (eg FDA, MHRA) assist in resolving audit observations as required. Work with supply chain colleagues to develop procedures which increase efficiency and maintain high quality standards. Responsible for collaboration with all relevant areas of global supply chain to ensure technical agreements with contractors are in compliance with Pfizer procedures. Drives application of quality risk management principles to the team's activities. Provide input to decisions for and participate as Person-in-Plant. Leverage partnership with COQA and MSQA to develop contract vendor oversight and management alignment, synergies and efficiencies. Providing QA GMP support through review and approval of packaging batch records/labels/transfers and receipts for clinical trial materials. Responsible for disposition of materials for clinical use. May be responsible for training as well as mentoring for new staff. Ensure compliance to filings via clinical supplies attributes and status of CMC amendments made to the filings. Ensure CMC regulatory release in CSDS as part of the release process May be required to provide support for release and disposition activities for Pfizer Internal Pharmacy Operations Education/Experience: Degree or equivalent work experience. Significant GMP experience working in a Quality Assurance, GMP manufacturing or R&D pharmaceutical environment. Strong interpersonal, negotiation, conflict management, oral and written communication skills Demonstrated experience with handling GMP compliance issues, resulting from GMP deviations or product defects; and may lead or contribute to significant quality investigations. Prior experience in management of external contractors is desirable. Prior QA experience in packaging/labeling is desirable. Hands-on knowledge of GDMS, Clinicopia, Trackwise, LIMS, CSDS & IVRS systems is desirable. Technical Skills Requirements: Detailed understanding and interpretation of the cGMPs, quality systems and GMP processes for the R&D environment. Knowledge of Clinical Trial process and R&D drug process, including knowledge of EU and US regulations. Knowledge on GMPs and regulations as related to supplier and vendor management programs. Able to make moderately complex day-to-day decisions and apply timely risk-based decision-making under minimal supervision. Able to take action on quality and compliance metrics and trends. Dedicated to problem solving and meeting the expectations of internal and external customers. Skills in planning, organization, leading Matrix teams and ability to apply technical skills in ambiguous situations. Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.