Sr. QA Executive

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 - hr@skanttr.com

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