Quality Control Team Leader

Role Summary:

• Our client has a new opportunity for a Quality Control Team Leader to support their Quality Control Department, based on their site in Co. Wicklow.
• The successful candidate will help to maintain quality standards throughout the company.
• The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.
• This is a 12 months contract (maternity cover).

Core Duties and Responsibilities:

• Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice.
• Implement and maintain standards of GLP practice consistent with regulatory expectation and cGMP.
• Responsible for all aspects of guidance of a team of QC analysts/technicians, including performance management and the execution of business processes to a high standard as monitored.
• Support your team and help them to perform to a high standard, in the achievement of the company and department goals.
• Inspire enthusiasm and stimulate interest and guiding staff to ensure they are productive.
• Safety, cGMP and Continuous Improvement.
• Ensure that Production, QA, Planning, Shipping and support departments receive a quality service through meeting scheduled target release dates and compliance standards.
• Training, recruitment, discipline and performing appraisals of QC analysts/technicians.
• To perform an investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
• Validation, operation, maintenance, calibration and troubleshooting of laboratory instruments.
• Approval of relevant QC documentation
• Support major Projects, quality plans and continuous improvement programmes within the department and in other.
• Prepare for and supporting external audits (HPRA, FDA, corporate, or client).
• Implement and maintain standards of safety to guarantee a safe working laboratory.
• Ensure that the laboratory is kept clean, tidy and safe.
• To highlight and implement new technologies in QC area.
• To maintain the validated status of the LIMS/Empower systems and other relevant systems and to manage them to assure compliance with acceptable regulations and company policies.
• Support of Annual Product Reviews.
• To act as designee for Manager; QC Laboratory in their absence.
• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values within the workplace.
• Actively foster, in cooperation with other TIL 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, Compliance or other Officer appointed by the Board of Directors.

Minimum Qualifications and Experience:

• (minimum) in science or a related discipline
• 5 years experience in an analytical lab preferably with supervisory responsibilities
• Technical experience of GC / HPLC Analysis required
• Experience with continuous improvement plans within the QC environment
• Experience managing, motivating and leading a team of analysts
• Promote teamwork by promoting a supportive and inclusive team atmosphere and to focus people on priorities and guide them to achieve their goals
• Address performance issues and establish specific plans to help team members reach goals
• Provide team members with, constructive feedback, coaching and support to help them recognize and on their strengths and development needs
• Good investigational and technical writing skills.
• Be a self-starter who is willing to learn.
• Strong Interpersonal & communication skills.
• Problem solving capability.
• Good organisational skills.

Please note, we do not require agency assistance with this role.