Process Incharge - Production (QMS)

Otsuka Pharmaceutical; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Otsuka Pharmaceutical seeks a production documentation specialist to prepare, review and control critical records for parenteral manufacturing. You will ensure GMP compliance, review shop-floor records, and lead investigations using root-cause tools like 5-Why and Fishbone.

You will initiate CAPA/Change Control activities, support validation and audits, and coordinate cross-functional teams to close QMS actions efficiently.

Qualifications

• Experience preparing critical production documents (BMRs, SOPs, logbooks, protocols).
• Familiarity with cGMP and GDP practices.
• Experience with incident and deviation investigations and root-cause analysis.
• Experience with CAPA and Change Control activities.
• Exposure to validation-related activities and audit support.

Responsibilities

• Prepare, review and control critical production documents for parenteral manufacturing, including BMRs, SOPs, logbooks, protocols and other related manufacturing records.
• Ensure compliance of production activities with cGMP, GDP, approved SOPs and established manufacturing procedures.
• Monitor and review shop-floor documentation and manufacturing records for completeness, accuracy and compliance with approved procedures.
• Lead and coordinate production-related incident and deviation investigations, including root-cause analysis using tools such as 5-Why and Fishbone; and ensure timely closure.
• Initiate, track and implement CAPA and Change Control activities related to production processes, equipment and documentation.
• Support Quality Risk Management activities related to manufacturing processes and identify opportunities for process and compliance improvement.
• Review production logbooks, online records and relevant audit trails to ensure proper documentation and traceability.
• Support preparation, review and execution of validation-related activities, including media fill documentation and protocols.
• Coordinate implementation of revised SOPs and procedures and provide training to production personnel on applicable GMP and documentation requirements.
• Support internal, customer and regulatory audits by providing required production records, QMS documentation and necessary shop-floor support.
• Maintain effective coordination with QA, Engineering, QC and other cross-functional teams for timely closure of production-related QMS activities.

Skills

Root-cause analysis

CAPA

Change Control

GMP knowledge

Documentation review

Cross-functional coordination

Tools

5-Why

Fishbone

Job description

• Prepare, review and control critical production documents for parenteral manufacturing, including BMRs, SOPs, logbooks, protocols and other related manufacturing records.
• Ensure compliance of production activities with cGMP, GDP, approved SOPs and established manufacturing procedures.
• Monitor and review shop-floor documentation and manufacturing records for completeness, accuracy and compliance with approved procedures.
• Lead and coordinate production-related incident and deviation investigations, including root-cause analysis using tools such as 5-Why and Fishbone; and ensure timely closure.
• Initiate, track and implement CAPA and Change Control activities related to production processes, equipment and documentation.
• Support Quality Risk Management activities related to manufacturing processes and identify opportunities for process and compliance improvement.
• Review production logbooks, online records and relevant audit trails to ensure proper documentation and traceability.
• Support preparation, review and execution of validation-related activities, including media fill documentation and protocols.
• Coordinate implementation of revised SOPs and procedures and provide training to production personnel on applicable GMP and documentation requirements.
• Support internal, customer and regulatory audits by providing required production records, QMS documentation and necessary shop-floor support.
• Maintain effective coordination with QA, Engineering, QC and other cross-functional teams for timely closure of production-related QMS activities.