Production Junior Associate , Associate ,Senior Associate – Drug Substance

Key Responsibilities:

Gain knowledge and understanding of applicable GxP requirements based on job profile, including cGMP, GDP, Data Integrity, GLP and other relevant trainings.

Provide guidance and recommendations to ensure compliance with Data Integrity (DI) and Good Documentation Practices (GDP).

Ensure all documentation is accurate, timely, legible, complete, and permanent in accordance with ALCOA principles.

Execute production process operations and monitor batch performance as per approved standard operating procedures (SOPs).

Ensure compliance with current Good Manufacturing Practices (cGMP) during all manufacturing activities.

Execute instructions related to production operations effectively and efficiently.

Adhere to Environmental Health & Safety (EHS) policies and procedures at all times.

Update Batch Manufacturing Records (BMRs) and other production documents in real time.

Ensure proper maintenance and utilization of raw materials as per production requirements.

Report, evaluate, investigate, and close deviations, CAPA, OOS, and OOT within defined timelines.

Ensure implementation and effectiveness of Corrective and Preventive Actions (CAPA) within the plant.

Coordinate with the Engineering department for timely maintenance of production premises and equipment.

Communicate and escalate process and facility related issues to higher management in a timely manner

Prepare, review, and revise SOPs, records, and other required documentation as necessary.

Implement and maintain GDP practices in accordance with ALCOA principles.

Conduct employee training programs and ensure all training records are maintained and updated.

Support and handle internal and external audits, ensuring audit readiness and compliance.

Required Skills & Competencies

Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.

1 - 6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations

Knowledge of cGMP, GDP, Data Integrity, and pharmaceutical manufacturing practices

Understanding of ALCOA principles and documentation compliance

Strong communication and coordination skills

Problem-solving and investigation handling capabilities

Ability to work in a regulated manufacturing environment

Familiarity with deviations, CAPA, OOS, and OOT management

Good documentation and reporting skills