Executive - API R&D

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd seeks an Executive in the R&D1 Regulatory Affairs unit. The role centers on supervising data for scale-up studies, executing lab/pilot scale-up experiments, and supporting tech transfer activities.

You will prepare process documentation, select equipment for batches, and help ensure GMP compliance throughout the development lifecycle. The candidate should hold a Bachelor's in Chemical Engineering and have 2–5 years of pharmaceutical experience, with a strong

Qualifications

• Experience in pharmaceutical industry quality systems and batch handling.
• Bachelor's degree in Chemical Engineering required.
• 2–5 years of relevant pharma experience preferred.

Responsibilities

• Monitor process scale-up studies in Lab/Pilot plant for tech transfer and scale-up.
• Carry out experiments and document observations in records.
• Select equipment for scale-up and support batch execution.
• Map equipment based on volume calculations from Kilo Lab and lab data.
• Prepare BPR, BOM and recipe and obtain approvals for batch startup.
• Ensure facility readiness: cleanliness, temperature control, equipment occupancy.

Skills

Process Scale-up

GMP Documentation

Experimental Work

Data Analysis

Education

Bachelor's Degree in Chemical Engineering

Job description

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Executive

Business Unit:

R&D1 Regulatory Affairs

Job Grade

Location:

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.

Job Description

• Monitor and compile data related to process Scale up studies in Lab/ Pilot plant to establish a robust process parameter for tech transfer & scale-up activity.
• To carry out the experiment and write the observation and records in specified experiment record.
• Selecting right equipment for scale up and provide support in the execution of scale up batches.
• Map the equipment’s based on the volume calculations from Kilo lab and lab data.
• Prepare the BPR, BOM & recipe and ensure their approval for batch start up.
• Monitor the facility readiness with respect to cleanliness, temperature blank trials, equipment occupancy etc.
• Be a part of member in performing Facility and Process Safety Analysis by conducting PHA & PSI, which includes What-If, HAZOP studies by coordinating with all CFT’s.
• Preparation/ review of MFD, PFD, P&ID’s, BPR and Utility calculation in coordination with CFT’s.
• Providing Technical supporting data for Incident Investigation of batch failures in order to find out and eliminate root causes.
• To prepare SLPs, SOPs, Development report, Troubles hooting report, justification report and all GMP documents related to PD Lab.

NA

Job Requirements

Educational Qualification

• Bachelor's Degree in Chemical Engineering (B.E./B.Tech Chemical Engineering)

Experience

• 2-5 years of experience in the pharmaceutical industry.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).