Team Leader, Quality Operation

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.

Responsibilities:

• Coordinate the team in timely identification and analysis of issues or events, proposing appropriate management approaches and collaborating with internal functions to identify root causes and propose suitable solutions.
• Ensure effective management of deviations and releases within specified timelines and quality standards to enhance customer satisfaction.
• Measure and supervise the efficiency of Corrective and Preventive Actions (CAPA).
• Collaborate with assigned departments and company functions to ensure compliance with quality standards, regulations, and customer agreements.
• Collect and analyze indicators related to assigned activities to identify potential risks, gaps, adverse trends, and recurrences, proposing solutions to improve performance or minimize risks.
• Participate in internal and external quality inspections conducted by clients and regulatory authorities.
• Facilitate training sessions for personnel engaged in Quality Operations activities and those working in the designated departments, following company protocols.
• Update Standard Operating Procedures (SOPs) related to the area of expertise as needed, ensuring compliance with current GMP requirements.
• Ensure accurate documentation storage.

REQUIREMENTS:

• Bachelor’s degree in CTF, Pharmacy, Chemistry, Biology, or a related scientific field, or equivalent experience.
• Knowledge of GMP/FDA regulations.
• Proven experience of at least 3 years in pharmaceutical production and/or quality assurance.
• Proficiency in English.
• Effective communication and active listening skills.
• Problem-solving and prevention approach based on data and analysis.
• Ability to work in a team.
• Focus on customer satisfaction.
  Thermo Fisher Scientific Inc. is an equal opportunity employer and values diversity in our workforce. We are dedicated to creating an inclusive and accessible environment for all individuals and offer reasonable accommodations to job seekers with disabilities.
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

• Coordinate the team in timely identification and analysis of issues or events, proposing appropriate management approaches and collaborating with internal functions to identify root causes and propose suitable solutions.
• Ensure effective management of deviations and releases within specified timelines and quality standards to enhance customer satisfaction.
• Measure and supervise the efficiency of Corrective and Preventive Actions (CAPA).
• Collaborate with assigned departments and company functions to ensure compliance with quality standards, regulations, and customer agreements.
• Collect and analyze indicators related to assigned activities to identify potential risks, gaps, adverse trends, and recurrences, proposing solutions to improve performance or minimize risks.
• Participate in internal and external quality inspections conducted by clients and regulatory authorities.
• Facilitate training sessions for personnel engaged in Quality Operations activities and those working in the designated departments, following company protocols.
• Update Standard Operating Procedures (SOPs) related to the area of expertise as needed, ensuring compliance with current GMP requirements.
• Ensure accurate documentation storage