QC Executive

CPL

Dublin South

QC EXECUTIVE RESPONSIBILITIES: Ensure that Production, QA, Planning and Shipping receive an effective quality service through meeting scheduled target release dates and compliance standards. To ensure that the Manager; QC Laboratory is kept informed and up to date of the status of the QC laboratory. To act as designee for Manager; QC Laboratory in their absence. Supervision of Senior QC Analyst Groups and associated QC analysts. Training, recruitment, motivation, discipline and performing appraisals of Senior QC Analysts and QC Analysts. Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with regulatory expectation and cGMP. Supervision of the quality control department resources (instruments and personnel) to provide a comprehensive analytical service for: - QC testing of raw materials / packaging materials/ intermediates / finished products/ clinical trial materials. - Stability / Water. - Technical Transfer / Validation of new and existing processes. To carry out the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times. Member of the Self-Inspection Audit Team. Assist in generation, implementation and control of QC annual budget for consumables, capital and headcount. Review and Approval of relevant QC documentation. To highlight and where necessary implement new technologies in QC area. Preparing for and supporting external audits (HPRA, FDA, corporate, client. Participate in the vendor certification programme as a lead auditor. Support major Projects, quality initiatives and continuous improvement programmes within the department and in other functional areas. Support the continuous improvement programme and projects within the QC laboratory. GENERAL RESPONSIBILITIES: Participate fully in any cross functional training initiatives. Drive and promote the corporate values of within the workplace. Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event. Ensure timely completion of all SOP, reading, training and assessment. Other duties as required and directed by the Manager, QC or other Officer appointed by the Board of Directors. EDUCATIONAL REQUIREMENTS: BSc. (minimum) in science or a related discipline. RELEVANT EXPERIENCE: Have relevant experience in the pharmaceutical industry. 5 years’ experience in an analytical lab preferable. Technical experience of GC / HPLC Analysis required. SKILLS/COMPETENCIES: Demonstrable experience managing, motivating and leading a team of analysts. Ability to promote teamwork by fostering a supportive and inclusive team atmosphere and to Focuses people on key priorities and guides them to achieve their goals. Ability to address performance issues on a timely basis and establishes specific plans to help team members reach objectives. Ability to provides team members with timely, constructive feedback, coaching and support to help them recognize and take action on their strengths and development needs. Ability to adapt to changing priorities. Good organizational, investigational & technical writing skills are required. Be a self-starter who is motivated & innovative. This job originally appeared on RecruitIreland.com.

2252 days ago