Assistant Manager

1. Job Purpose

To manage and monitor production operations and Production Quality Management System (QMS) activities at the OSD formulation plant, ensuring compliance with cGMP, Good Documentation Practices, approved SOPs, and applicable regulatory requirements. The role involves production process monitoring, process validation documentation, deviation investigation, CAPA, change control, and coordination with cross-functional departments to ensure product quality and operational compliance.

2 .Role & responsibilities

Key Responsibilities

A. Production Operations and Process Monitoring

• Monitor and coordinate production operations in granulation, capsule filling, tablet compression, and coating areas.
• Ensure operation and monitoring of production equipment in accordance with approved SOPs and established operating procedures.
• Ensure area readiness, line clearance, equipment cleaning, and completion of associated documentation before commencement of manufacturing activities.
• Monitor critical process parameters, in-process checks, yields, and batch manufacturing activities to ensure compliance with approved manufacturing instructions.
• Ensure proper execution and documentation of manufacturing and packing activities, as applicable.
• Identify and report process deviations, abnormalities, and equipment-related issues and coordinate appropriate corrective actions.
• Ensure compliance with approved manufacturing procedures, GMP requirements, and safety practices.

B. Production Documentation and Good Documentation Practices

• Handle and review production documentation in accordance with cGMP and Good Documentation Practices (GDP).
• Ensure completeness, accuracy, traceability, and timely completion of Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), equipment logbooks, and other applicable records.
• Ensure appropriate documentation of process parameters, in-process checks, yields, line clearance, equipment cleaning, and manufacturing activities.
• Prepare, review, revise, and implement production-related SOPs, formats, and work instructions.
• Ensure compliance with data integrity principles, including ALCOA+, wherever applicable.
• Identify documentation discrepancies and coordinate appropriate corrections and follow-up actions in accordance with approved procedures.

C. Deviation Management and Investigation

• Initiate, coordinate, investigate, document, and track production-related deviations through closure within defined timelines.
• Perform root cause analysis using appropriate investigation tools, such as 5 Why Analysis and Fishbone Diagram.
• Assess the impact of deviations on product quality, process performance, batch integrity, and patient safety, in coordination with QA and other relevant departments.
• Prepare scientifically justified investigation reports with supporting evidence, root cause conclusions, and appropriate corrective and preventive actions.
• Coordinate with QA, QC, Engineering, and other relevant functions to obtain investigation inputs and complete assigned actions.
• Monitor overdue deviations, identify recurring issues, and support implementation of measures to prevent recurrence.

D. CAPA and Change Control Management

• Raise, coordinate, and monitor QMS activities, including deviations, CAPA, and change controls, as applicable.
• Coordinate change control initiation, impact assessment, risk evaluation, implementation, and closure for production-related changes.
• Ensure changes involving manufacturing processes, equipment, utilities, and documents are implemented only after obtaining the required approvals.
• Track CAPA action plans, ensure timely implementation, and coordinate effectiveness checks.
• Monitor recurring deviations and quality issues and recommend appropriate preventive measures.
• Maintain accurate records and periodic status reports for assigned QMS activities.

E. Process Validation

• Prepare and coordinate Process Validation Protocols and Reports for applicable OSD manufacturing processes.
• Coordinate with QA, Validation, QC, Engineering, and Production teams for execution of validation activities.
• Ensure validation protocols define the scope, objectives, responsibilities, acceptance criteria, sampling requirements, and documentation requirements, as applicable.
• Compile and review process validation data, manufacturing observations, process parameters, and supporting documentation for report preparation.
• Document deviations observed during validation activities and coordinate their investigation and closure.
• Ensure validation documentation is complete, traceable, and compliant with approved protocols and applicable regulatory requirements.

F. SOP Preparation and Document Control

• Prepare, review, revise, and periodically review SOPs, formats, and work instructions related to production operations and QMS activities.
• Ensure documents are aligned with current manufacturing practices, approved procedures, and applicable GMP requirements.
• Coordinate document review, approval, issuance, and implementation with the relevant departments.
• Ensure personnel are trained on new or revised SOPs before implementation, as applicable.
• Follow up on pending document revisions and ensure timely completion of assigned documentation activities.

G. Audit and Regulatory Compliance

• Support internal audits, self-inspections, customer audits, and regulatory inspections related to Production and QMS.
• Provide relevant production records, validation documents, deviation reports, CAPA records, and change control documentation during audits and inspections.
• Coordinate responses and corrective action plans for production-related audit observations.
• Track audit-related actions and ensure timely implementation and closure.
• Maintain production areas and documentation in an inspection-ready state.
• Ensure compliance with applicable cGMP requirements, relevant Schedule M provisions, approved SOPs, and regulatory guidelines.

H. Cross-Functional Coordination and Continuous Improvement

• Coordinate with QA, QC, Engineering, Validation, Warehouse, and other relevant departments for production and quality-related activities.
• Monitor QMS timelines, including deviation closure, CAPA implementation, change control completion, and document revision.
• Prepare and review trend reports for deviations, documentation errors, and recurring process issues.
• Identify opportunities to improve manufacturing practices, documentation compliance, and QMS effectiveness.
• Guide production personnel on GDP, deviation reporting, SOP compliance, and relevant QMS procedures.
• Ensure adherence to applicable safety procedures and promote a culture of quality and compliance within the department.

Preferred candidate profile

Educational Qualification

• B.Pharm / M.Pharm preferred.
• B.Sc. / M.Sc. in a relevant scientific discipline may also be considered, subject to organizational requirements.

Experience and Technical Competencies

• 8-12 years of experience in pharmaceutical manufacturing, preferably in an OSD formulation plant.
• Practical experience in production operations, including granulation, capsule filling, tablet compression, and coating.
• Strong hands-on experience in Production QMS, deviation investigations, root cause analysis, CAPA, and change control.
• Experience in preparation of process validation protocols and reports.
• Sound knowledge of BMR/BPR documentation, GDP, cGMP, data integrity, and SOP management.
• Experience in audit support, risk assessment, and cross-functional coordination.
• Working knowledge of MS Office and electronic QMS/document management systems is desirable.

Key Skills

• Strong investigation, analytical, and problem-solving skills.
• Good technical writing and documentation skills.
• Effective coordination and communication with cross-functional teams.
• Ability to manage multiple activities and meet defined timelines.
• Attention to detail and commitment to quality, data integrity, and compliance.
• Ability to identify process gaps and drive continuous improvement.

Key Performance Indicators (KPIs)

• Timely initiation, investigation, and closure of deviations.
• Timely completion and effectiveness verification of CAPAs.
• Timely preparation and completion of process validation documentation.
• Compliance with GDP, cGMP, approved SOPs, and manufacturing procedures.
• Reduction in recurring deviations and documentation errors.
• Timely closure of change controls, audit actions, and document revisions.
• Maintenance of complete, accurate, and inspection-ready production and QMS records.