Manager

Experience: Not Available to Not Available years

Location: Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

Skills: cGMP, Validation, Regulatory Compliance, Documentation Practices, SAP

Key Result Areas (KRAs)
1. GMP Documentation Management
• Preparation, review, and control of GMP documents such as:
1. BMR/BPR
2. SOPs
3. Protocols & Reports
4. Change Controls
5. Formats and logbooks
• Ensure documentation compliance as per cGMP and data integrity requirements.

2. Technology Transfer & Current Product Introduction
• Support successful technology transfer activities from R&D; to manufacturing.
• Coordinate new product introduction activities and process implementation.
• Ensure smooth execution of scale-up and exhibit/commercial batches.

3. Validation & Qualification Activities
• Preparation and review of:
1. Process Validation documents
2. Cleaning Validation documents
3. Qualification protocols and reports
• Coordinate validation activities with cross-functional departments.

4. Deviation, Investigation & CAPA Management
• Review and support closure of deviations, OOS/OOT investigations, and CAPA.
• Ensure timely implementation and effectiveness tracking of corrective and preventive actions.

5. Cross-Functional Coordination
• Coordinate with:
1. R&D;
2. Production
3. QA
4. QC
5. Regulatory Affairs
6.



Packaging Development
• Ensure timely completion of technical and documentation-related activities.

6. Manufacturing & Compliance Support
• Review executed manufacturing and packaging records.
• Provide technical support during manufacturing activities and troubleshooting.
• Support internal, external, customer, and regulatory audits.

7. Regulatory & QMS Compliance
• Ensure adherence to:
1. cGMP guidelines
2. Quality Management System (QMS)
3. Regulatory requirements
• Maintain audit readiness and compliance documentation.

Additional Tasks / Responsibilities
• Coordination of artwork approval, print proof review, and customer approvals.
• SAP-related documentation entries and tracking activities.
• Participation in risk assessment and change management activities.
• Monitoring document archival, retrieval, and issuance control.
• Support training activities related to SOPs, GMP, and documentation practices.
• Follow-up with departments for timely closure of pending action items.
• Preparation of technical summaries, trend reports, and compliance data as required by management.
• Support continuous improvement initiatives within Technical Services and Production functions.
• Ensure proper communication and escalation of critical technical or compliance issues.

📌 Manager (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad