Senior Executive, Intermediate Cleanroom

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

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