Sathiyaraj P

Key Responsibilities & Skills

Shift Supervisor – Powder Filling & PFS | D2 DMS, QMS, MES & Manufacturing Commissioning

1.Worked as Shift Supervisor for Dry Powder Filling and Pre-Filled Syringe (PFS) filling lines, ensuring compliant and uninterrupted injectable manufacturing.

2.Managed end-to-end shift operations, including manpower allocation, line readiness, batch execution, and shift handover.

3.Supervised aseptic powder filling (vials) and PFS filling operations in compliance with cGMP, aseptic practices, and contamination control strategy.

4.Executed and verified line clearance, batch start-up, in-process controls, and batch close-out as per approved BMR/BPR and MES workflows.

5.Acted as QMS Supervisor for the shift, handling deviations, incidents, OOS/OOT support, and quality events.

Performed root cause analysis (5-Why, Fishbone) and supported CAPA implementation and effectiveness verification.

6.Managed D2 DMS activities, including SOP preparation, revision, issuance, periodic review, training assignment, and document archival.

7.Ensured ALCOA+ data integrity compliance across paper records, D2 DMS, and MES electronic batch records.

8.Supported MES execution, including electronic batch record review, workflow adherence, exception handling, and user compliance.

9.Actively involved in manufacturing commissioning activities for powder and PFS lines, including:

Equipment installation and start-up support

IOQ/PQ and process trial execution

Utility and equipment readiness verification

10.SOP finalization and operator training

Supported Media Fill (APS), smoke studies, filter integrity tests, and hold time studies during routine and commissioning phases.

11.Monitored environmental monitoring (viable & non-viable), differential pressure, temperature, and RH, ensuring timely action on excursions.

Coordinated with QA, QC, Engineering, Microbiology, Automation, and Warehouse for smooth shift and commissioning activities.

12.Trained and qualified operators and executives on powder filling, PFS operations, SOPs, MES usage, and aseptic behavior.

13.Supported internal, customer, and regulatory audits (USFDA, MHRA, WHO, EU GMP) by presenting production, QMS, DMS, and MES records.

14.Ensured compliance with EHS guidelines, safe powder handling, and cleanroom discipline during routine and commissioning operations.

15.Drove continuous improvement initiatives to reduce deviations, improve right-first-time execution, and enhance productivity.

Filling (Shift In-Charge & SME)

1.Functioned as Shift In-Charge and Subject Matter Expert (SME) for aseptic filling operations, ensuring compliance with cGMP, regulatory, and 2.contamination control requirements.

Owned end-to-end shift operations, including planning, execution, monitoring, and shift handover for injectable manufacturing.

3.Provided technical leadership and on-floor decision making during critical aseptic operations and deviations.

Supervised and guided executives, operators, and contract manpower, ensuring optimum productivity with zero compromise on quality.

4.Led aseptic filling of Vials, PFS, Cartridges, and Lyophilized products using isolator/RABS technology.

5.Acted as SME for aseptic practices, gowning qualification, cleanroom behavior, and contamination control strategy.

6.Executed and verified line clearance, batch start-up, in-process checks, and batch close-out as per approved BMR/BPR.

7.Played a key SME role in Media Fill (APS), smoke studies, EM programs, filter integrity tests, and hold time studies.

8.Monitored and assessed environmental monitoring trends and excursions, implementing immediate corrective and preventive actions.

Initiated, investigated, and closed deviations, incidents, and quality events, performing root cause analysis and driving CAPA effectiveness.

9.Reviewed and supported Change Controls, risk assessments (FMEA), and process improvements.

Ensured ALCOA+ data integrity compliance across batch records, logbooks, and electronic systems.

10.Acted as first point of contact for QA, Microbiology, Engineering, and QC during shift-related quality and technical issues.

11.Supported internal, customer, and regulatory audits (USFDA, MHRA, WHO, EU GMP) as an SME, providing technical justifications and evidence.

Conducted on-job training, mentoring, and qualification of team members on aseptic operations and SOP compliance.

Drove continuous improvement initiatives to reduce deviations, enhance productivity, and strengthen compliance culture.

12.Ensured EHS compliance and safe operations within aseptic manufacturing areas.

Shift Supervisor – Aseptic Vial Filling (Isolator Line)

Senior Executive – Aseptic PFS Filling, Manufacturing, QMS & SME