QA Executive

Job Description:
  • Experience: 04 to 06 Years
  • CTC: Upto 03 Lakh
  • Gender: M/F
  • Openings: 5
  • Department: Quality Assurance - QMS/Documentation
  • Dosage Form: Injectables - Liquid Injections

Note: Only from Finished Formulation candidate need to apply.

Responsibilities:

The Quality Assurance Executive will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organizations products and/or development processes.

Role Description:
  • Candidate must have Liquid Injectable (Sterile facility) working Experience.
  • Must have knowledge of Knowledge of the cGMP/GDP/QMS, ICH guidelines.
  • Tracking and trending closure of deviation, OOT and change control.
  • Issuance, retrieval and tracking of incidents, deviations, Change Control & OSS forms.
  • Reviews SOP base on any changed pharmacopeial requirement or feedback from shop floor or any comments from previous audit, incorporate changes, inform supervisor seek appropriate approval and authorisation to ensure update of SOPs.
  • Update of Site Master File (SMF) with necessary changes as and when required.
  • Review the log books for online entries and its correctness.
  • Ensure the timely revisions and availability of currents SOPs.
  • Ensure the SOPs are in line with the practice and revision thereof if required.
  • Facilitate timely completion and effective implementation of QMS system.
  • Ensure batch records are disposed-off on time.
  • Issuance of incident/deviation forms.
  • Review of master BMR/BPR and issuance of BMR/BPR.
  • Review and preparation of the SOP work instruction of related departments and verify compliance.
  • Online review and report of GMP non-compliance to QA Head.
  • Review of incidents and deviations related to exhibit, validation & qualification batches.
  • Co-ordinate with QA, QC, Production and another functional departments for maintaining Quality standards and to have a continuous compliance as per regulatory requirements.
  • To identify and implement process improvement opportunities, cost improvement and monitor the effectiveness of the same.
  • Optimize usage of all existing resources, identify new/additional resources as required.
  • Participate in periodic reviews.
Skills Required:
  • Good Communication Skills
  • Good Analytical Skills
  • Thinking & Decision Making Skill.
Apply Now:

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