Executive - CQA - Linux Laboratories - Chennai

Role & responsibilities

Job Description (CQA Executive)

• Handling of quality management system (Change Control system, Deviation, Incident, CAPA, Customer/Market Complaints etc.,).
• Preparation, review & issuance of Standard operating procedures.
• Responsible to organize, archive and review of all product related documents (i.e. COA, Spec, STP, BMR, BPR, APQR, Stability, License, artworks etc.,) from CMOs.
• Responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA).
• Responsible for the execution of the companys supplier audit & Contract laboratory audit program.
• Responsible for the execution of the company’s internal audit program.
• Monitoring of Compendia / Pharmacopeia revisions or any additions which impacts system and procedures.
• Responsible in collecting and compiling monthly quality data reports that will be presented in management review meetings.
• Responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory and company requirements.
• Responsible for review and approval artworks.

Preferred candidate profile

Pharmaceutical formulation

Perks and benefits

As per industry standard