Quality Assurance Supervisor
Quality Assurance Supervisor - Co. Wicklow. 12 months fixed-term contract. PURPOSE OF THE POSITION: Supervise and manage the daily operations of the Quality Assurance group. Manage site regulatory and cGMP activities and compliance. This compliance to be maintained with the implementation of effective SOPs and systems, validation of test methods equipment and processes, cGMP training programs and effective auditing and self-inspection programs. Lead and develop QA personnel and to develop Best Practice cGMP systems. Deputise as Quality Manager. ESSENTIAL JOB FUNCTIONS (key accountabilities): • Support all site Health, Safety & Environment initiatives and requirements and ensure support of same from reports. • Assist the Quality Manager in overseeing and managing all Quality Assurance Systems within the facility. • Investigation reporting including Process Deviation, OOS, Material failures and customer complaints. • Review and approval of batch related documentation and final product release. • Provide Regulatory and cGMP leadership to all Site and Business Unit Functions. • Provide a QA input to (and manage, as necessary) company validation programmes. • Ensure the cleaning validation protocol and programs are progressed in accordance with current cGMP norms. • Supervise all Quality Assurance personnel activities and ensure they are carried out in a compliant and timely manner. • Complete QA audits, inspections and investigations in a timely manner consistent with shipping deadlines. • Investigate customer complaints and regulatory queries thoroughly, in a timely manner and ensure that all corrective and preventive actions are fully implemented. • Foster and instill a Continuous Improvement culture within QA and QA related activities. • Lead and train QA team on detailed Root Cause Analysis investigations related to relevant site and product quality requirements. • Preparation of APRs, DMFs and other recurring cGMP requirements in a timely manner. • Maintain an up-to-date knowledge of current international cGMP trends and cascade this to all reports and to Site Leadership. • Oversee the Plant Documentation and Change Control system including drafting of SOP’s, Monographs and Master Batch Records. • Ensure full Quality group participation in company improvement functions. • Provide continuous improvement leadership in QA activities to secure process efficiencies and enhancements. • Act as liaison point with Regulatory agencies as necessary. • Act as Lead Host in cGMP audits in the absence of the Quality Manager. • Prepare, authorise, manage and ensure delivery of the company cGMP training programme. • Supervise, recruit and develop QA staff and deal with any staff issues arising in conjunction with Quality Manager and HR. • Assist in departmental and company goal setting in accordance with Site and Corporate strategic goals, with special emphasis on cGMP goals. QUALIFICATIONS and Experience Sought: Essential: Relevant Science based 3rd-level qualification with relevant regulatory experience. Experience/key achievements: Significant experience at Senior Quality level, in a FDA regulated company. Broad experience of regulatory and cGMP activities. Proactive Individual with Change Agent Capabilities. Ability to identify, plan and implement improvement activities. Skills/Knowledge: Critical: Excellent oral and written communication skills. Good attention to detail and good organisational skills. Mature judgment, problem solving and decision-making ability. Essential: Previous supervisory experience with the ability to operate in a team based environment or proven track record in a similar role. This job originally appeared on RecruitIreland.com.
188 days ago