Job Description

: How Will You Make an Impact? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. W : How Will You Make an Impact Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit What will you do When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Position Summary: Reporting to the QC Manager Chemistry, the role is responsible for Building a new, state-of-the-art, GMP QC lab from the ground up. This role is responsible for writing laboratory procedures, transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical raw materials, intermediates and products. The role contributes to building and maintaining QC lab cGMP system, delivers analytical solution to clients through specific method qualification and validation strategies while ensuring timely delivery for projects. The role will include performing testing for incoming materials, in-process products and DS testing, etc. Responsibilities: To support new equipment qualification, lab computerized system and new chemistry lab set up To perform transfer/verification/validation of laboratory procedures within the team where required To prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications, investigations and reports. To perform analysis of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies. To review analytical and laboratory data within the department for accuracy, completeness and compliance with documented procedures. To perform planned preventative maintenance and performance calibrations on equipment. Management of QC chemical, reference standard and consumable stock levels To maintain own training records To communicate effectively with others on site Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab Support and encourage a 'Quality Culture' and company 4i values throughout QC Ensure cGMP is applied in their area of work and comply with cGMP in all areas of the business. To work with HSE, cGMP and 5S in mind at all times. Undertake ad-hoc activities that may be required by the business To support shift work (if necessary) in future EH&S: Understand emergency procedures and comply with safe systems of work. Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules Minimum Requirements/Qualifications: Degree in Chemistry or strongly related scientific discipline At least 2 years relevant industrial experience Ability to apply GMP regulations and other international guidelines to all aspects of the position. Ability to work independently and adhere to critical timelines Effective communication skills at all internal and external levels Excellent attention to detail Excellent organisational skills