Job Description

Essential Functions:

Prepare new SOPs and revise existing SOPs based on periodic updates and internal/external audit recommendations. Review, implement, and ensure adherence to approved SOPs within the Production Department. Coordinate and execute process validation and cleaning validation activities in collaboration with QA, QC, and R&D. Review validation protocols and reports to ensure acceptance criteria are met for new molecules and process changes for existing molecules. Ensure compliance with cGMP, USFDA guidelines, and safety standards in the production area. Promote a safe working environment and ensure subordinates follow safety procedures and PPE requirements. Ensure continuous audit readiness of plant facilities for internal, external, and regulatory audits. Review audit observations and prepare, implement, and close CAPAs within defined timelines. Monitor and review cleanroom environmental parameters such as temperature, humidity, and differential pressure (Level II & III). Verify and ensure completeness and accuracy of GMP documents including BMR, BPR, BCR, equipment logs, and related records. Ensure strict adherence to SOPs and cGMP requirements during manufacturing operations. Initiate and manage online incidents, deviations (planned/unplanned), and change controls for new and existing products. Investigate OOS, incidents, deviations, and batch failures; identify root cause or probable root cause and prepare investigation reports. Initiate, implement, evaluate effectiveness, and close CAPAs with proper documentation. Prepare and review BMR/BPR/BCR for new products and scale-up of existing products as per R&D process inputs. Revise manufacturing documents based on audit findings, validation results, and RA recommendations. Prepare equipment and process mapping documents including process flow diagrams, risk assessments, change summaries, and equivalency reports. Maintain updated lists of authorized personnel, organograms, SOPs, change controls, CAPAs, deviations, OOS, incidents, errata, equipment, and risk assessments. Prepare and review protocols and reports for area qualification, requalification, calculator validation, and Excel sheet validation. Prepare limit calculation sheets (LCS) for cleaning validation of new and existing API products. Generate and manage online training through AIMS software and ensure training compliance. Provide functional and cross-functional training to newly joined and existing employees as per training need identification. Coordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA departments for documentation, compliance, and investigation activities. Coordinate with QA for document issuance/submission and with Warehouse for RM, intermediates, and API issuance/submission. Ensure timely inventory management of plant and process-related consumables. Execute batch processing activities as per SOPs, BMR, BPR, and BCR and maintain equipment usage logs. Perform, record, and maintain all GMP documents online in compliance with cGMP requirements.

Additional Responsibilities:

Support implementation of continuous improvement and process optimization initiatives. Assist in equipment qualification and process validation as per regulatory expectations. Ensure shop floor discipline, GMP compliance, and data integrity practices. Support regulatory inspections and customer audits by providing required documentation and explanations. Participate in risk assessments, safety drills, and incident investigations. Train, guide, and mentor junior staff and operators on GMP and safety practices. Ensure adherence to environmental, health, and safety norms in chemical handling and waste disposal. Actively participate in cross-functional meetings related to production planning and compliance.

Skills:

API Production Operations - Advanced SOP Preparation & Documentation Control - Advanced cGMP & USFDA Compliance - Advanced Process & Cleaning Validation - Intermediate to Advanced Deviation, CAPA & Change Control Management - Advanced Batch Documentation (BMR/BPR/BCR) - Advanced Audit Readiness & Regulatory Inspection Handling - Intermediate to Advanced Training Management (AIMS) - Intermediate Cross-functional Coordination - Advanced Safety, Risk Assessment & Data Integrity - Intermediate

Qualifications:

Education:

Master Degree - M.Sc (Chemistry / Organic Chemistry) - Preferred B.E / B.Tech - Chemical Engineering - Required

Experience:

* 8 to 10 years of experience in API manufacturing with strong exposure to GMP, validation, and audits