QA - Executive

Job description

Responsibilities:

  • Responsible for framing, controlling and issuance of Standard Operating Procedures (SOPs) and guidelines for all the key operations across various functions at site.
  • To ensure the issuance/archival & retrieval of documents.
  • To plan & execute the internal quality audit & documentation/data review as per the defined frequency
  • To record the key/live observations during the actual audit
  • To investigate the cause of any non-conformance & its corrective/preventive action.
  • Guiding the team(s) the ways in which they can reduce the noncompliant observations
  • Publishing reports, observations and the corrective as well as preventive actions discussed/suggested/taken
  • To ensure the proper archival & storage of final compounds & intermediates as per the defined process
  • Maintaining master files/documents/registers (hard/soft).
  • Maintaining through record of all its activities and observations.
  • Conducting regular and surprise personal inspections to monitor effectiveness of the implemented QMS

Job requirements

  • Have knowledge of analytical instruments like HPLC, LCMS etc.
  • Have basic knowledge of calibration process of instruments.
  • Knowledge of cGMP, GLP, GDP & QM
  • Have a passion for QA as well as being open to continuous learning and education
  • Be highly organized with the ability to work independently in a fast paced team environment
  • Ability to work in a team in a transparent and entrepreneurial culture
  • Self-motivated with initiative to reach challenging targets
  • Outstanding business writing and proofing skills
  • Exceptional attention to detail
  • Positivity, focus and a winning mentality allied with kindness
  • Curiosity, energy, creativity, and bravery with a strong desire to help to build the o2h culture