Third Party Operations (Production)

Opes Healthcare; Ahmedabad; On-site; INR 240,000 - 480,000; Full time

Job summary

Opes Healthcare in Changodar is seeking a fresher to join the Third-Party Operations team. You will support and coordinate third-party manufacturing across LL and TP sites, ensuring timely production, documentation, and quality compliance.

You will work with QA/QC, prepare PIFs, assist in BMR/BPR review, and travel to sites as required to monitor activities under cGMP guidelines. This role offers exposure to multiple dosage forms and cross-functional collaboration.

Qualifications

• Bachelor’s or Master’s degree in pharmacy or related science field.
• Fresher; willingness to travel to third-party sites as required.
• Knowledge of cGMP and pharmaceutical documentation is desirable.

Responsibilities

• Assist in managing day-to-day third-party manufacturing activities across LL/TP locations.
• Coordinate with QA/QC and LL/TP manufacturing sites for routine activities.
• Prepare and review Product Information Forms (PIFs) and regulatory records.
• Support BMR/BPR preparation and documentation verification before batch release.
• Monitor in-process activities and maintain proper records as per SOPs.

Skills

Coordination

Documentation

Quality monitoring

Interdepartmental coordination

Education

B.Pharm / M.Pharm / M.Sc

Job description

Role & responsibilities

Department: Third-Party Operations
Experience: Fresher
Qualification: B.Pharm / M.Pharm / M.Sc
Location: Changodar

Role Definition

To support and coordinate third-party manufacturing operations across Loan Licence (LL) and Third-Party (TP) manufacturing locations. Assist in production monitoring, technical documentation, interdepartmental coordination and quality compliance to ensure smooth manufacturing and timely execution of activities.

Key Responsibilities

1. Third-Party Operations

• Assist in managing day-to-day third-party manufacturing activities across LL/TP locations.
• Support manufacturing operations for different pharmaceutical dosage forms.
• Coordinate with LL/TP sites to ensure smooth execution of production and packaging activities.
• Visit manufacturing sites as required to understand and monitor operational activities.

2. Coordination & Communication

• Coordinate with PPMC, QA, QC and LL/TP manufacturing sites for routine operational activities.
• Follow up with third-party manufacturers regarding production schedules and pending activities.
• Assist in collecting and coordinating technical documents from manufacturing sites.

3. Documentation Management

• Assist in preparing and reviewing Product Information Forms (PIFs).
• Maintain approved PIF records in soft and hard copies.
• Collect and maintain valid product and manufacturing site licence copies.
• Assist in preparing and reviewing Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
• Maintain proper records of third-party manufacturing documentation.

4. Production & Quality Monitoring

• Assist in monitoring in-process activities during manufacturing and packaging.
• Ensure proper recording and documentation of production activities under the guidance of the concerned team.
• Support BMR/BPR review and documentation verification before batch release.
• Follow applicable cGMP guidelines, SOPs and internal quality procedures.

5. Quality Management System

• Assist in documentation and follow-up of deviations, change controls and CAPA.
• Coordinate with QA/QC teams for quality-related documentation.
• Support process validation activities at LL/TP manufacturing sites.

6. Technology Transfer

• Assist in technology transfer activities for commercial products at third-party manufacturing sites.
• Coordinate with internal technical teams and external manufacturers for required documents and follow-ups.
• Support technical teams during site visits and technology transfer activities.

7. Material & Vendor Coordination

• Follow up for the availability of placebo materials and working standards.
• Assist in coordinating technical requirements with third-party manufacturers.
• Maintain vendor-related records and commercial agreement documentation.

8. Continuous Improvement

• Identify and communicate operational challenges to the reporting manager.
• Support continuous improvement initiatives at third-party manufacturing sites.
• Perform any other responsibilities assigned by management from time to time.

Additional Requirement

• Must be willing to travel and visit third-party manufacturing sites as and when required.
• Should be comfortable with outstation travel for manufacturer visits, production follow-ups and coordination.