Quality Operations Support

6 days ago

Kurkumbh Pune Maharashtra, India The closing Gap Full time

**Job Title**: Quality Operations Support / ITQA

**Location**: Kurkumbh, Maharashtra
**Industry**: Pharmaceutical Manufacturing
**Salary Range**: ₹15,000 - ₹30,000 per month
**Department**: Quality / Manufacturing / Compliance

**Job Type**: Full-Time | On-site

**About the Company**

We are a leading pharmaceutical manufacturing organization with a strong commitment to regulatory compliance, operational excellence, and global quality standards. Our Kurkumbh facility is equipped with modern infrastructure to support the production and packaging of high-quality pharmaceutical products for domestic and international markets.

**Position Overview**

We are hiring a Quality Operations Support professional who will work closely with the Quality and Production departments to ensure manufacturing and packaging operations are conducted in compliance with cGMP and standard operating procedures. This role involves real-time monitoring, documentation, system operations, and assisting in audits and quality processes.

**Key Responsibilities**

Operational Oversight
- Monitor in-process checks during primary and secondary packaging operations, including blister, bottle, sachet, and drum formats.
- Provide support during line clearance and changeover procedures.
- Record machine output, wastage, and ensure process parameters are maintained and documented correctly.
- Coordinate with production teams to ensure timely and accurate batch documentation and reconciliation.

Documentation and System Management
- Review and maintain Batch Packing Records (BPRs), logbooks, shift handover reports, and other GMP-related documents.
- Ensure proper usage and data entry in systems such as SAP, LMS, PRAMAAN, ICMS, Leucine E-log, and E-Track.
- Issue and update Standard Operating Procedures (SOPs) and manage distribution control.
- Maintain audit trails and user access logs for manufacturing and quality systems.

Compliance and Quality Coordination
- Ensure manufacturing and packaging activities are carried out in accordance with cGMP and regulatory requirements.
- Assist in internal and external audits by organizing documents and providing compliance evidence.
- Verify calibration certificates, datalogger reports, and ensure equipment/system readiness for operation.
- Support the handling of deviations, change controls, and CAPA implementation processes.

**Qualifications**:

- Diploma, B.Sc., B.Pharm, or equivalent qualification in Life Sciences, Chemistry, or Pharmaceutical Sciences.

Experience
- 0-3 years of relevant experience in pharmaceutical manufacturing, packaging, or quality support roles.
- Experience with GMP documentation and system tools preferred.

Technical Skills
- Basic understanding of packaging operations and quality systems.
- Familiarity with SAP, PRAMAAN, LMS, ICMS, and electronic documentation systems.
- Knowledge of regulatory guidelines and good documentation practices.

Soft Skills
- High attention to detail and compliance-focused mindset.
- Good written and verbal communication skills.
- Ability to work collaboratively with production and QA teams.

**What We Offer**
- Competitive salary commensurate with experience and qualifications.
- Opportunities for career development in quality, production, or compliance.
- Exposure to GMP-regulated systems and processes.

**Application Process**

**Job Types**: Full-time, Permanent

Pay: ₹19,401.57 - ₹35,249.23 per month

Schedule:

- Rotational shift

Work Location: In person

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