Job Title: Assistant Manager / Manager- Gene Therapy (QA)
Competencies
Purpose of Job
Responsible for to support the implementation and maintenance of GMP-compliant systems in R&D and manufacturing facility for Cell and Gene Therapy .
The role involves assisting and ensuring compliance during product development, operational readiness and regulatory documentation.
Skill Required
Good understanding of GMP regulations and quality systems.
Strong documentation and compliance skills.
Ability to work collaboratively with cross-functional teams.
Familiarity with aseptic techniques and cleanroom operations.
Roles and Responsibilites
Providing QA oversight for development and manufacturing activities.
Provide QA input during equipment qualification, commissioning, and validation.
Review qualification and validation documentation for compliance.
Review and support method and process development, technology transfer and process validation activities.
Review batch records and ensure adherence to GMP requirements.
Assist in documentation for process development and comparability studies.
Assist in deviation management, CAPA tracking, and change control processes.
Maintain training records and ensure timely completion of GMP training.
Promote adherence to quality standards across teams.
Promote Good documentation practices and data integrity principles.
Qualification Required
MSc, MPharm, MTech
Relevant skills / Industry experience
Equipment qualification, Facility commissioning, and validation.
Process development and comparability studies.
Deviation management, CAPA tracking, and change control processes.
Good documentation practices and data integrity principles.
Awareness on GT and CGT
Relevant professional / Educational background
MSc, MPharm, MTech
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213