Sr. QA Executive

1 week ago

Ahmedabad, Gujarat, India Skanttr Lifescience LLP Full time ₹ 2,00,000 - ₹ 12,00,000 per year

Skanttr Lifescience LLP (API Manufacturing)

Location - Bavla , Ahmedabad

Key Responsibility

Documentation & Compliance

  • Preparation, review, and control of SOPs, protocols, and quality documents.
  • Review and issuance of BMR (Batch Manufacturing Record) / BPR (Batch Packaging Record).
  • Ensure compliance with cGMP, GLP, and regulatory requirements (USFDA, EU, WHO, MHRA, etc.)

Audits & Inspections

  • Participate in internal audits, vendor audits, and regulatory inspections.
  • Support in CAPA (Corrective and Preventive Actions) implementation.

Change Control & Deviation Handling

  • Documentation and investigation of deviations, incidents, OOS, and OOT results.
  • Execution of change control, risk assessment, and quality system improvements.

Validation & Qualification

  • Support in process validation, cleaning validation, method validation, and equipment qualification.
  • Review of validation protocols and reports.

Training & Awareness

  • Conduct training on quality systems, SOPs, and regulatory updates.
  • Promote quality culture within the organization.

Other QA Activities

  • Line clearance and in-process checks in production and packaging.
  • Review and approval of analytical documents (COAs, specifications, test reports).
  • Support in QMS (Quality Management System) activities.

Key Skills Required:

  • Sound knowledge of cGMP, ICH, WHO, and regulatory guidelines.
  • Strong documentation and record-keeping skills.
  • Hands on experience in IPQA Activities
  • Good analytical and problem-solving ability.
  • Excellent communication and teamwork skills.
  • Proficiency in MS Office, QMS tools, and documentation software.

Job type - Full-time, Permanent

Salary - Best in the industry as per candidates capabilities

Email ID -

Job Type: Full-time

Benefits:

  • Provident Fund

Education:

  • Master's (Preferred)

Experience:

  • Quality assurance: 2 years (Preferred)

Location:

  • Ahmedabad, Gujarat (Required)

Willingness to travel:

  • 25% (Preferred)

Work Location: In person

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