Executive - API R&D

SUN PHARMA; Vadodara; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Sun Pharma in Vadodara is seeking an Executive for the R&D1 Regulatory Affairs unit to monitor process scale-up data and assist tech transfer. You will compile observations, help select equipment, and ensure batch start-up readiness with a focus on GMP compliance.

The role requires hands-on experimental work, precise documentation, and collaboration across functions to support process safety studies and development reporting.

Qualifications

• Bachelor’s degree in Chemical Engineering required.
• 2-5 years of experience in the pharmaceutical industry.
• Experience with process scale-up and GMP documentation.

Responsibilities

• Monitor and compile data for process scale-up studies in Lab/Pilot plant.
• Carry out the experiment and record observations in the experiment record.
• Select equipment for scale-up and provide support in batch start-up.
• Map the equipment based on the volume calculations from Kilo Lab and lab data.
• Prepare BPR, BOM & recipe and ensure approval for batch start-up.
• Monitor facility readiness with respect to cleanliness, temperature blank trials, equipment occupancy.
• Participate in Facility and Process Safety Analysis by conducting PHA & PSI with CFTs.
• Prepare/ review MFD, PFD, P&ID’s, BPR and Utility calculations with CFTs.
• Provide technical data for incident investigations of batch failures to identify root causes.
• Prepare SLPs, SOPs, development reports, trouble shooting reports and GMP documents related to PD Lab.

Skills

Scale-up

Data recording

Documentation

Equipment selection

Education

Bachelor's Degree in Chemical Engineering

Tools

Kilo Lab

PFD/MFD/P&ID

Job description

Job Title

Executive

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A

Location

Vadodara

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.

Travel Estimate

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).