Executive/Sr . Executive - Production

10 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Purpose:

To manage and execute day-to-day manufacturing operations in accordance with cGMP guidelines, safety protocols, and regulatory requirements, ensuring timely production with high quality and compliance.

Key Responsibilities:

•        Supervise and execute manufacturing activities of Oral Solid Dosage forms (Granulation, Compression, Coating,

etc.) as per batch manufacturing records (BMRs).

•        Ensure adherence to GMP, SOPs, and regulatory guidelines during manufacturing operations.

•        Monitor equipment usage, cleaning, and maintenance; raise breakdown and calibration requests when

required.

•        Coordinate with cross-functional teams (QA, QC, Stores, Maintenance, and Engineering) for smooth operations.

•        Review and maintain all necessary documentation including BMRs, logbooks, deviation reports, change

controls, and CAPAs.

•        Train and guide operators and junior staff on SOPs, safety procedures, and good documentation practices.

•        Support readiness and face regulatory audits (USFDA, MHRA, TGA, etc.) and customer inspections.

•        Monitor yield, minimize product loss, and identify areas for continuous process improvement.

•        Ensure proper material handling and line clearance before and after batch processing.


Qualification - B.Pharm / M.Pharm

Experience - 8–10 years in a regulated pharmaceutical manufacturing unit (preferably OSD)

Regulatory Exposure, Must have handled operations during USFDA and other regulatory audits

Skills

Sound knowledge of cGMP, GDP, and manufacturing equipment

Strong documentation and compliance mindset

Problem-solving and decision-making abilities

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