Deputy Manager, Manufacturing

Essential Functions
JOB DESCRIPTION

• Prepare new Standard Operating Procedures (SOPs) as required and revise existing SOPs based on periodic updates, audit recommendations, and regulatory changes.
• Review and implement approved SOPs for the Production department.
• Carry out process validation and cleaning validation activities in coordination with R&D, QC, and QA.
• Review acceptance criteria for new molecules and modified processes for existing molecules; ensure validation protocols and reports are reviewed and approved.
• Ensure cGMP and safety compliance within the production area, maintaining a safe working environment for all subordinates.
• Ensure the production area and documentation are always audit-ready for internal, external, and regulatory inspections.
• Review audit reports, provide CAPA for all observations, and ensure effective CAPA implementation.
• Monitor and review temperature, humidity, and differential pressure records in clean areas (Level-II & Level-III).
• Ensure all required documents are maintained as per cGMP and USFDA guidelines and verify BMR, BPR, and BCR entries for accuracy and completeness.
• Ensure strict adherence to SOPs and cGMP practices during manufacturing operations.
• Initiate and close online incidents, deviations (planned/unplanned), and change controls for new and existing products with proper supporting documentation.
• Investigate OOS (Out of Specification), incidents, and deviations; prepare reports identifying root cause/probable cause and CAPA; ensure effectiveness review and timely closure.
• Prepare and review BMR, BPR, and BCR for new products and for enhanced batch sizes of existing products as per R&D process guidance.
• Revise BMR/BCR documents based on audit findings, validation results, and RA (Regulatory Affairs) recommendations.
• Prepare equipment and process mapping details, change summaries, equipment/process comparison sheets, risk assessments, errata, and process flow diagrams.
• Maintain updated lists of authorized personnel, production area organogram, SOP revision lists, and logs for change controls, CAPA, deviations, OOS, incidents, and risk assessments.
• Prepare and review protocols and reports for area qualification/requalification, calculator validation, and Excel sheet validation for weighing balance accuracy and precision checks.
• Conduct intermediate re-analysis documentation for re-test period extension as per quality guidance.
• Generate and manage online training in AIMS software through coordination with respective departments.
• Conduct functional and cross-functional training for new joiners and existing employees as per training needs and competency matrices (including BMR/BCR/LCS training).
• Prepare Limit Calculation Sheets (LCS) for cleaning validation of new products and existing products with enhanced batch sizes or equipment changes.
• Coordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA departments for documentation and compliance activities.
• Coordinate with QA for document issuance/submission and with Warehouse for RM/Intermediate/API issuance and reconciliation.
• Maintain inventory of plant/process-related consumables.
• Execute batch processing activities in compliance with SOPs, BMR, BCR, and BPR; maintain detailed equipment usage logs and ensure timely completion of records.
• Record and maintain all documentation online as per cGMP and data integrity requirements.
• Complete all assigned online training modules via AIMS software.

Additional Responsibilities

• Support implementation of document control systems and continuous improvement in manufacturing documentation practices.
• Participate in internal audits and ensure timely response to observations.
• Contribute to preparation for regulatory audits and ensure readiness of documentation and records.
• Provide data support for product lifecycle management, validation, and regulatory submissions.
• Promote good documentation practices (GDP) across production teams.
• Ensure all records are archived as per company document retention policy.

Qualifications
Education:

• B.E. / B.Tech in Chemical Engineering – Required
• M.Sc in Organic or Industrial Chemistry – Preferred

Experience

• Minimum 8 years of experience in API Manufacturing (QMS Documentation / Production Documentation section).

Skills

• GMP Documentation & Record Management – Advanced
• SOP Preparation, Revision & Implementation – Advanced
• Validation Documentation (Process/Cleaning) – Advanced
• Deviation, CAPA, and Change Control Management – Advanced
• QMS & Audit Readiness – Advanced
• Root Cause Analysis and Investigation – Intermediate to Advanced
• Regulatory Compliance (cGMP/USFDA) – Advanced
• Process & Equipment Mapping – Intermediate
• Training and Knowledge Transfer – Intermediate
• Team Coordination & Communication – Intermediate