Assistant Manager Production

Job Summary:

To supervise, manage, and optimize production activities in the OSD manufacturing facility while ensuring compliance with cGMP, safety, and regulatory standards.

Key Responsibilities:

Receiving of API and Packaging materials from warehouse.

Supervise the Dispensing, Granulation, Blending, Compression, Coating, Encapsulation and Packaging operations of OSD products as per GMP standards.

Understanding of cGMP, GDP, and regulatory audit expectations.

Prepare SOPs as per guidelines.

Ensure 100% compliance of monthly production schedule.

Ensure timely issuance and submission of BMRs & BPRs for each batch.

Ensure good documentation practices are followed & logbooks, BMRs and BPRs are timely updated.

Manage supply plan as per demand.

Manage resources for smooth operation and maintain machine and labor utilization.

Coordinate with R&D and validation for new developments and qualification.

Key Requirements:

At least a Pharm D degree.

5-8 years of experience with Good Manufacturing Practices (GMP) specific to OSD manufacturing.

Familiarity with regulatory guidelines such as FDA, EMA, WHO, and local drug authorities.

Expertise in Batch Manufacturing Records (BMRs), SOPs, deviation handling, and CAPA.

Knowledge of equipment i.e., blenders, tablet press, granulators, Dry powder filling machine and blister.

Strong leadership and team management.

Problem-solving and decision-making ability.

Excellent communication and interpersonal skills.

Attention to detail and compliance-driven.