QA/QP Manager

COLLINS MCNICHOLAS RECRUITMENT

WESTMEATH

Position Summary. The successful person will hold responsibility for all QA/QP activities in support of the process through to product release. The role will provide support to the Director of Quality and Regulatory Affairs in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA and EU regulations. Key Responsibilities. The QM/QP will develop and maintain a clear compliant quality strategy which will ensure cost-effective and smooth quality and product release processes to include the following responsibilities: The Quality Manager is responsible for overall development, implementation, and maintenance of the organisation’s Quality Management System. Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation. In collaboration with the Management Team, drive continuous improvement and best practices in our clients/vendor quality systems. Manage all quality system and quality control activities within the quality team. Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex Volume 4 and Directive 2001/83/EC to support disposition of Products. Perform final release of the pharmaceutical product. Manages the batch disposition process to ensure timely release of products. Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements. Independently initiate and approve SOP updates and creation of new SOPs. Additionally, oversee review of SOPs and associated documentation to ensure review requirements are met. Conduct supplier audits and contractor audits. Facilitating, approving and providing inputs into change controls, investigations and nonconformance reviews as required. Provide Quality support to site projects. Evaluation of CMO’s Quality Management Systems to ensure the appropriate level and content of reporting, including technical evaluation of quality system reports. Maintaining and improving quality metrics that incorporate continuous improvement methodologies. Ability to independently represent the quality function at project meetings and make sound decisions in support of project needs ensuring quality needs are understood and implemented. Education and Experience. Job Qualifications (Minimum Requirements): An MSc in Pharmaceutical Science or similar course recognised by HPRA to permit Qualified Person status as per Article 49 of Directive 2001/83/EC. At least 5 years’ experience in the Pharma industry within the quality function. Experience of working within a FDA and EMA regulated environment. Excellent People Management Skills. Excellent Organisation, Report Writing, Communication, Problem Solving and Presentation Skills. Sound Decision Making and Negotiation capabilities. Essential Skills/Core Competencies. Proven to be self-directed, self-motivated and ability to prioritise competing priorities. Relationship Building: Establishing excellent working relationships within the qualify team and with all functions within the business. Excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner. Identify and understand issues, problems and opportunities whilst providing a viable solution. Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints. For a confidential discussion or more information on the role, please contact David Lennon. Tel: 0906478104. Email: david.lennon@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1615 days ago