Deputy Manager, Manufacturing

Essential Functions:

• 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