Quality & Validation Manager

ICDS Recruitment

Offaly

Quality & Validation Manager. Su mmary of Role: This is a key role in the establishment and management of the site Validation Master Plan. The Validation Manager will lead all validation activity across the Manufacturing, Laboratory and Warehouse facilities. Ke y Responsibilities: Assist with the setup & implementation of an effective quality management system including quality oversight and leadership across the site and supply chain related activities undertaken. Provide input into the creation, modification and maintenance of the Quality Management. Systems supporting operational and release functions. If qualified act as a back up QP onsite. Participate in or lead internal and external audit including 3rd party audits and supplier reviews. Establish and maintain the site validation plan and all associated validation activities. Manage and coordinate validation activities as defined in the validation master plan. Serve as technical expert for the Validation process and responsibilities to ensure compliance. Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives. Review and approve Validation Plans, Protocols, Summary Reports and other documentation associated with validations and ensure compliance. Initiate and implement change control activities in accordance with site procedures Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities. Oversee the execution of Process Equipment Installation and Operational Qualifications, review and approve the Qualification protocols, discrepancies and reports. Interface with external consultants and suppliers to ensure successful process and equipment validation. Manage the site cleaning validation schedule and ensure CSV compliance across the site. Present validation system programmes at internal and external audits as required. Write or assist in writing, reviewing and approval of SOPs for Validation andotherProjects Develop and where appropriate deliver training across the teams regarding the validation programme and metrics. Qualification/Experience: BSc, MSC, PhD in a relevant discipline (e.g biochemistry, chemistry, process engineering. or equivalent experience. At least 3-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment. 3 years management or supervisory experience in a bioprocess development and/or validation/quality assurance environment. Good knowledge of regulatory guidelines relating to process development and manufacture including QbD and Risk Management. Ability to write relevant sections of CTD for regulatory submission. Va l ue s: Employees must conduct themselves in accordance with the company values at all times. We promote: • Adaptability and responsiveness. • Teamwork and collaboration. • Integrity and respect. • Accountability. This job originally appeared on RecruitIreland.com.

2496 days ago