Sr. QA Executive
1 week ago
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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