Job Title: Sr. Executive / Executive - Development QA
Competencies
Purpose of Job
Skill Required
Roles and Responsibilites
Review of analytical/process department related data and documents with respect to accuracy, adequacy, completeness and data verification from LNBs, DRS, BMR etc.
To review the documents like Protocol, Reports, SOP etc.
To review the regulatory query response.
To review the QMS documents like change control, deviation, investigation etc
To review the electronic data verification as per the requirements.
To participate in the internal and external audit as per requirement.
To prepare the SOP as per requirement.
To manage the additional responsibilities like Cell bank management, LNB issuance etc.
To ensure cGMP/ GLP compliance at R&D
Qualification Required
Msc or Mpharma - Biotechnology is preffered
Relevant skills / Industry experience
Candidate with More than 3 years of relevant experince in Biosimilars indutry is prefered
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213