At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Position summary:
Reporting to the QC Manager Chemistry, the role is responsible for building a new, pioneering, GMP QC lab. 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 gives to building and maintaining QC lab cGMP system, delivers analytical solution to clients through expertise in specific method qualification and validation strategies while ensuring timely delivery for projects. The role will be driving activities such as 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 detailed 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 and support and train other team members as required.
- Participate/chip 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 align 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
Keys to Success:
Education
- Degree in Chemistry or strongly related scientific field
Experience
- At least 3 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
- Excellent attention to detail
- Excellent organisational skills
