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