Posted in: Other in United Kingdom | Posted: |
An Excellent opportunity for a QA Compliance Manager to work as part of the Global Product Quality team for a well known pharmaceutical client . You will be part of and contribute to the management and maintenance of the quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, and that the QA unit fully complies with all relevant legislation and industry recommended practice
Strong QA experience, preferably with complaint handling experience. * Experience of medicinal product and medical device quality systems * 5+ years' experience minimum. * Experience with electronic quality systems. * Preferably experience of dealing with contract manufacturers
High attention to detail * Very good written and spoken English * Excellent time Management & organisational skills * Ability to pro-actively identify issues and seek resolution * Experience in management of GMP/GDP Quality Management Systems * Experience of Electronic Document Management Systems * Additional relevant QA experience * Excellent written and verbal communication skills * Ability to learn quickly and adapt quickly to changing requirements * Ability to work to tight deadlines * Good problem solving skills * Knowledge of regulations pertaining to both medicinal products and medical devices
Ensure Company products are fit for their intended use, comply with the requirements of the relevant Marketing Authorisation (MA) and do not place patients at risk due to inadequate safety, quality and efficacy. * Implement the Quality System, communicate requirements to all affected staff and monitor its performance. * Manage and resolve any GMP/GDP / regulatory compliance issues that arise. * Drive quality improvement initiatives. * Ensure staff training & development to fulfil the needs of the overall business * Review and approve change controls, deviations, CAPAs, non-conformances and customer complaints * Review and authorise company documents e.g. SOPs, Quality Agreements, Artwork, Specifications, Validation etc. * Review and approval of batch records
Provide metrics on quality system performance. * Approve validation activities relating to the introduction of new processes, methods, or equipment, and/or any changes. * Provide training support for other departments and affiliates as required. * Communicate with other affiliates to ensure product complaint handling, and if necessary product recall, is adequately undertaken. * Promote a positive approach to quality both internally and externally. * Manage and host audits from third parties or regulatory bodies. * Act as deputy for Director - Global Product Quality, as delegated. * Provide input to CMC section of marketing authorisation applications and submissions. * Ensure that the requirements and conditions of marketing authorisations and submissions are reflected in the manufacturing, technical, and testing processes and procedures.
Ensure that the requirements and conditions of the Company's product licences and authorised devices are reflected in the manufacturing, technical, and testing processes and procedures. * In conjunction with the Director - Global Product Quality * Ensure that quality control laboratory testing is performed in an efficient, cost effective manner, whilst meeting all regulatory requirements. * Review and approve quality specifications, analytical methods and stability plans. * Provide support in the planning and scheduling of laboratory testing. * Initiate follow-up action on out of specification materials. * Liaise with contractors on sample quantities and sampling frequency. * Ensure stability testing is performed in accordance with the requirements of the marketing authorisations. Additional Activities * Provide support to other functions within the Global Product Quality team.
Parkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer