Title QA Executive
Services Quality Assurance
Job Function Quality Assurance
Job Grade Professional P2
SBU/ Division Inogent – API
Candidate Profile Qualification M.Sc./M.Pharm.-Chemistry (Organic/Analytical)
Experience 3 – 6 years
Job Responsibilities
    To handle validation activities :

  • Preparation of Method Transfer activities, Review of Stabilitydata and SOPs, Specifications, MOAs, ATR and Raw data.
  • Prepare and seek approval of process & drying validation protocols and their reports
  • Preparation and review Quality control specification, MOA,protocols & Photo stability protocols
  • Issuance and review of Batch Manufacturing Record and equipment cleaning records and QC department Specification, MOA& Raw data.
  • Ability to conductonline(self-inspection)audits in accordance with SOPs
  • Archiving of documents like validation protocols, validation reports, validation BMRs, specification & MOA
  • Act as point of contact for archival of obsolete documents
  • Preparation of Annual Review Reports.
  • Zero deviation from SOPs/ norms/ regulatory requirements & escalate deviations (if any)
    Ensure Good Documentation Practices (GDPs) :

  • Accurate & up-to-date technical documents in accordance with regulatory compliance
  • Archival & retrieval of documents
  • Prepare / review documents / reports as maybe required
    Maintain records, data integrity & safety :

  • Maintain strict data integrity and adhere to all related policies
  • Understand & adhere to safety norms
    Ensure skill development of self:

  • Enhance knowledge in the work area through formal and informal means of learning
  • Focus on developing behavioral competencies through behavioral workshops and feedback discussion with manager