Chemistry Quality Control Manager

MSD

Carlow

Job Description. Are you our next Chemistry Quality Control Manager? An opportunity is now available where you will be responsible for managing and co-ordinating the oversight of our new state of the art lab facility. Through collaboration with a number of cross functional teams and support for your team you will support the day to day running’s of our lab to ensuring KPIs are reached for each Drug Substance/Drug Product Manufactured material tested. Bring energy, knowledge, innovation to carry out the following: Work closely with the Associate Director of Quality Control (Chemistry) according to Company safety policies, cGMP and cGLP. Drive compliance with Our Company Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.  Leadership activities including selection, development, coaching, and day to day management. Oversight of testing and release from the laboratory of all Drug Substance and Drug Product manufactured at the site to ensure successful KPIs. Oversight and SME input on all Laboratory Investigations to ensure completion to the highest GMP standards. Oversight and review of Laboratory testing trends and partnership with Technical Engineering on any trend concerns.  Ensure that the Laboratory team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs. Operationalize Quality by leveraging MPS tools to ensure value stream lead times are achieved. Manage laboratory budget and costs and ensure financial compliance within the team. Develop financial awareness for all team members. Drive and promote a culture of compliance both safety and quality. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and procedures for various systems; ensure all work is subsequently carried out in line with same. Liaise with Site MPS and the Quality CI Lead to drive continuous improvement with compliance and quality systems, including investment in new technology to enable efficiencies. Liaise with cross functional teams on site, in particular QC Operations, IPT (integrated process teams), Automation Compliance, Regulatory, Technical Engineering and Commissioning and Qualification teams to ensure regulatory requirements are met. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility. Provide Analytical chemistry SME sponsor to site. May be required to perform other duties as assigned and act on behalf of the Associate Director of Chemistry in their absence. What skills you will need: In order to excel in this role, you will more than likely have: Third level qualification (Degree) in a science related discipline, ideally in Chemistry, Biochemistry or equivalent. 10 plus years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in operations environment. As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Current Employees apply HERE. Current Contingent Workers apply HERE. Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. .

910 days ago