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 - [email protected]

Job Type: Full-time

Advantages:

- Provident Fund

Application Question(s):

- What is your current CTC?
- What is your expected CTC ?
- Notice period ?

Education:

- Master's (Preferred)

Experience:

- Quality assurance: 2 years (Preferred)

Location:

- Ahmedabad, Gujarat (Required)

Willingness to travel:

- 25% (Preferred)

Work Location: In person

📌 QA Executive (Ahmedabad)
🏢 Skanttr Lifescience
📍 Ahmedabad