Job Description

Company information 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 efficiency in their laboratories, we are here to support them. Our global team of more than 75,000 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 www.thermofisher.com. Position Summary: Reporting to the QC Manager Chemistry, the role is responsible for

• Building state-of-the-art, GMP QC Chemistry 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 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 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 (including HPLC and GC) 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 optimally with others on site
• Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab
• Support and encourage a \xe2\x80\x9cQuality Culture\xe2\x80\x9d 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

Eh&s:

• Understand emergency procedures and align 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 field
• 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
• Excellent attention to detail
• Excellent organisational skills

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission\xe2\x80\x94enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.