Production - Sterile - Sr. Officer

USV PRIVATE LIMITED; Daman; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

USV PRIVATE LIMITED is seeking a Senior Officer for Production Sterile: Aseptic to lead daily aseptic filling, stopper insertion, and lyophilizer loading in Grade A/B suites. You will ensure strict adherence to aseptic processes and ALCOA+ data integrity.

You will coordinate Aseptic Process Simulations, sign off line clearances, and support audits by USFDA, EU Annex 1, and WHO. The role requires hands-on leadership in a GMP environment and strong EHS/5S practices.

Qualifications

• Experience in aseptic manufacturing environments.
• Strong ALCOA+ data integrity knowledge.
• BMR execution and batch record familiarity.
• Knowledge of cleanroom standards and gowning.
• Audit support and CAPA implementation experience.
• Hands-on with equipment qualification protocols.
• Ability to lead RCA investigations in GMP settings.
• Familiarity with GMP standards (USFDA/EU).
• Supervisory experience in sterile operations.
• EHS and 5S best practices.

Responsibilities

• Lead daily aseptic filling, stopper insertion, capping, and lyophilizer loading to hit production targets.
• Enforce EU Annex 1 aseptic guidelines and cleanroom gowning.
• Execute and verify BMR and logbooks per ALCOA+.
• Sign off on Type A/B line clearances and SIP/CIP verifications.
• Perform bubble point and water intrusion tests; adjust fill weights.
• Coordinate Aseptic Process Simulations (Media Fills) and shift coverage.
• Lead RCA investigations for aseptic excursions and CAPA.
• Support equipment qualification activities (IQ/OQ/PQ) and validation.
• Represent QA during audits (USFDA, EU Annex 1, WHO).
• Enforce EHS, 5S and mentor junior staff in aseptic core discipline.

Skills

Aseptic Core Supervision

Aseptic Technique

BMR & ALCOA+ Data Integrity

Line Clearance & Setup

Filter Integrity Testing

Aseptic Process Simulation

QMS Investigation & RCA

Equipment Qualification & Validation

Audit Representation (USFDA/EU)

EHS & 5S Leadership

Tools

IQ/OQ/PQ Validation

Job description

Production Sterile: Aseptic – Senior Officer

• Aseptic Core Supervision: Lead daily aseptic filling, stopper insertion, capping, and lyophilizer loading operations inside Grade A/B processing suites to hit production targets safely.


• Aseptic Technique & Annex 1 Compliance: Enforce strict adherence to EU Annex 1 aseptic behavior guidelines, cleanroom airflow dynamics (LAF/RABS/Isolators), and multi-stage cleanroom gowning qualification.


• BMR Execution & ALCOA+ Data Integrity: Execute and verify real-time Batch Manufacturing Records (BMR) and equipment logbooks, maintaining strict adherence to ALCOA+ data integrity principles.


• Line Clearance & Aseptic Set-Up: Perform and sign off on Type A/B line clearances, aseptic setup of filling needles/tubing, and sterilization-in-place (SIP) / cleaning-in-place (CIP) routine verifications.


• Filter Integrity & In-Process Checks: Execute pre- and post-use bubble point / water intrusion filter integrity tests, perform line fill-weight adjustments, and supervise environmental sampling routines.


• Aseptic Process Simulation (Media Fills): Participate in and help coordinate biannual Aseptic Process Simulations (Media Fills), managing shift schedules, interventions, and failure mode testing.


• QMS Investigation & RCA Lead: Initiate and drive shop-floor Quality Management System tasks, leading Root Cause Analysis (RCA) for aseptic interventions, environmental excursions, deviations, and CAPA execution.


• Equipment Qualification & Validation: Support floor execution of equipment qualifications (IQ/OQ/PQ), thermal mapping, velocity matrix checks, and cleaning/sterilization validation protocols.


• Audit SME Representation: Act as a front-line Subject Matter Expert (SME) during internal and regulatory audits (USFDA, EU Annex 1, WHO), presenting aseptic filling records and room intervention logs.


• EHS, 5S & Team Guidance: Enforce cleanroom Environmental Health & Safety (EHS) policies, oversee 5S discipline, and mentor junior officers, trainees, and technicians on aseptic core discipline.