Officer, Manufacturing Documentation

Role overview

This position is responsible for supporting manufacturing documentation and quality compliance activities at the Hyderabad site. The role focuses on maintaining GMP standards, managing quality records, supporting investigations, and ensuring timely closure of corrective and preventive actions across departments.

Key responsibilities

• Ensure safety practices are followed within the facility in line with company standards.
• Manage quality system documents such as change controls and deviations.
• Draft investigation reports for quality-related deviations, out-of-specification events, and non-conformances.
• Make sure investigations are completed and closed within the required timelines to support business needs.
• Support cGMP compliance by helping implement and close CAPAs on time.
• Review, improve, and introduce procedures and working methods that help the department meet business requirements within agreed timelines and GxP expectations.
• Carry out risk assessments for different processes and procedures, and apply mitigation measures through quality risk management.
• Provide guidance and support to other functions during investigations.
• Conduct internal audits according to the approved schedule across functions.
• Prepare and review SOPs and protocols.
• Perform gap assessments for Batch Manufacturing Records, Batch Packing Records, SOPs, and protocols, and start corrective actions where needed.
• Take part in regulatory and customer audits.
• Assess and investigate market complaints.
• Train team members on different processes and procedures.
• Coordinate effectively with different internal functions.
• Prepare Batch Manufacturing Records and Batch Packing Records.
• Complete assigned SOP training on time.
• Prepare and periodically update SOPs related to the QMS area.
• Carry out other tasks assigned by the HOD as required, following instructions and guidance.

Qualifications

The required qualification for this role is B.Pharmacy.

Additional information

This is a full-time, onsite role based in Hyderabad, Telangana, India.