Site Quality Lead

About the job

Work Schedule

Standard (MonFri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers 22degrees Office Will work with hazardous/toxic materials

Site Quality Lead

Thermo Fisher Scientific Inc. is looking for a motivated and experienced professional to join our team in Ahmedabad as a Site Quality Lead. In this role you will be responsible for ensuring that clinical supplies are stored and distributed in compliance with Fisher Clinical Services approved procedures and policies as well as industry regulations such as cGMP cGDP. This position offers a chance to contribute to highquality systems and work closely with both internal and external partners on qualityrelated issues.

Job Responsibilities:

Ensure compliance with internal standards local and international quality and regulatory guidelines for clinical trials supply chain activities

Deliver monthly reporting on key performance indicators and provide insights on trends risks and mitigation plans

Provide guidance and advice on regulatory and quality matters to clients suppliers and internal associates

Handle internal and external audits and followup on resulting observations and opportunities for improvement

Mentor and develop the Quality team to deliver outstanding results

Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business

Lead management reviews of process performance product quality and the Pharmaceutical Quality System advocating for continual improvement

Establish effective communication processes to ensure timely reporting of quality issues to the appropriate levels of management.

Take a leadership role in service and quality improvement initiatives

Job Requirements:

Bachelors degree or equivalent experience in life science/medical/pharmacy/quality assurance/regulatory affairs or related field

5 years of strong QA and production experience or experience in GMP/QMS settings in quality assurance and regulatory affairs

Knowledge of IMP process including handling complex protocols and key clients

Ability to handle complex problems/projects with independent decisionmaking and analytical thinking skills

Flexible adaptable and strong customer management skills

Ability to work independently under pressure and handle multiple tasks

Strong leadership and influencing skills

Good organizational written and verbal communication skills in English

Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

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Remote Work :

No