Senior Production Executive

BDR Pharmaceuticals; Vadodara; On-site; INR 900,000 - 1,200,000; Full time

Job summary

BDR Pharmaceuticals in Vadodara seeks a QA/QMS Specialist to lead production documentation, ensure cGMP/GDP compliance, and manage deviations, CAPA and change controls across the production floor. You will coordinate audits, track CAPA timelines, maintain SOPs and training records, and support line clearance and batch release activities in line with Schedule M and WHO-GMP requirements.

Strong documentation skills and cross-functional collaboration are essential to promote a culture of quality

Qualifications

• Strong knowledge of cGMP, GDP and Data Integrity.
• Hands-on experience with Deviations, CAPA, Change Control and Incident Management.
• Experience in SOP preparation and document control.
• Familiarity with SAP Production Module and regulatory expectations (WHO-GMP, Schedule M).
• Excellent documentation, analytical and cross-functional coordination skills.
• Proficient in MS Excel, Word and PowerPoint.

Responsibilities

• Prepare, review and ensure timely execution of GMP documentation for production.
• Manage BMR/BPR, logbooks and production formats; ensure GDP and data integrity.
• Coordinate Deviations, CAPA, Change Controls and incident investigations.
• Support audits, responses and ensure timely closure of observations.
• Train and maintain GMP/QMS records; ensure line clearance and batch release support.
• Perform SAP transactions related to production documentation and MIS reporting.
• Coordinate with QA, QC, Warehouse, Engineering and EHS for QMS activities.

Skills

cGMP

GDP

Data Integrity

Deviations

CAPA

Change Control

Incident Management

Batch Documentation

SOP Preparation

Document Control

SAP Production

Regulatory Knowledge

Cross-functional Coordination

Communication Skills

Tools

SAP Production Module

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Key Responsibilities

QMS & Documentation

• Ensure timely preparation, review and execution of all production-related GMP documentation.
• Handle issuance, retrieval, reconciliation and archival of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), logbooks and production formats.
• Prepare, review and update SOPs, Formats, Protocols and Work Instructions as per the document control system.
• Maintain department documentation in compliance with cGMP, GDP and Data Integrity requirements.
• Ensure timely closure of documentation observations and compliance gaps.

Quality Management System

• Coordinate and monitor Deviations, Change Controls, CAPA and Incident investigations related to Production.
• Perform root cause analysis and support implementation of effective CAPA.
• Track QMS timelines and ensure timely closure in coordination with QA and cross-functional departments.
• Support Risk Assessment activities and implementation of quality improvement initiatives.

Production Compliance

• Ensure all production activities are performed in accordance with approved SOPs and cGMP guidelines.
• Monitor documentation practices on the shop floor and ensure Good Documentation Practices (GDP).
• Ensure compliance with regulatory requirements including Schedule M, WHO-GMP and applicable internal quality standards.
• Coordinate with QA during line clearance, batch release documentation and routine compliance activities.

Audit & Inspection

• Coordinate and support Internal Audits, Self-Inspections, Customer Audits and Regulatory Audits.
• Prepare responses for audit observations and ensure timely implementation of corrective and preventive actions.
• Maintain audit readiness of the Production Department at all times.

Training

• Conduct and coordinate departmental GMP, SOP and QMS-related training.
• Maintain training records and ensure employee qualification compliance.
• Promote quality culture and GMP awareness among production personnel.

Production Coordination

• Coordinate with Production, QA, QC, Warehouse, Engineering and EHS departments for smooth execution of QMS activities.
• Support production planning by ensuring documentation readiness before batch initiation.
• Assist shift teams in resolving documentation and compliance-related issues.

System & SAP Activities

• Perform SAP transactions related to production documentation, material movements and batch status as applicable.
• Maintain departmental trackers and prepare daily, weekly and monthly MIS reports.
• Monitor pending QMS activities and submit periodic compliance reports to department management.

Required Skills

• Strong knowledge of cGMP, GDP and Data Integrity principles.
• Hands-on experience in Deviations, CAPA, Change Control and Incident Management.
• Sound understanding of Batch Manufacturing Documentation.
• Experience in SOP preparation, review and document control.
• Working knowledge of SAP (Production Module preferred).
• Good understanding of regulatory requirements such as WHO-GMP and Schedule M.
• Excellent documentation, analytical and problem-solving skills.
• Strong communication and cross-functional coordination abilities.
• Proficiency in Microsoft Excel, Word and PowerPoint.

Preferred Experience

• Experience in API, Pharmaceutical or Life Science manufacturing.
• Exposure to Internal, Customer and Regulatory Audits.
• Experience handling QMS activities independently within the Production Department.

Key Competencies

• Quality & Compliance Orientation
• Attention to Detail
• Documentation Excellence
• Analytical Thinking
• Planning & Organizing
• Team Coordination
• Decision Making
• Ownership & Accountability
• Continuous Improvement
• Effective Communication