Job Description

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