Executive - API RandD

SUN PHARMA; Vadodara; On-site; INR 650,000 - 950,000; Full time

Job summary

Sun Pharma in Vadodara seeks an Executive to support scale-up studies in the R&D1 Regulatory Affairs unit. The role involves data compilation, process transfer, and ensuring GMP-compliant documentation.

You will oversee experiments, select equipment for scale-up, map lab data, and prepare BPR/BOM/recipes for batch start-up while coordinating with CFTs for safety analyses. With a BE Chemical Engineering and 2–5 years in pharma, you will collaborate across teams to drive successful tech transfers

Qualifications

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

Responsibilities

• Monitor and compile data for process scale-up studies to establish robust process parameters for tech transfer and scale-up activities.
• Carry out experiments and record observations in the specified experiment records.
• Select appropriate equipment for scale-up and support batch execution.
• Map equipment based on volume calculations from Kilo lab and lab data.
• Prepare BPR, BOM and recipes and obtain necessary approvals for batch start-up.
• Monitor facility readiness including cleanliness, temperature blank trials and equipment occupancy.
• Coordinate with CFTs for PHA/PSI and safety analyses (What-If, HAZOP).
• Prepare/ review MFD, PFD, P&ID, BPR and utility calculations with CFTs.
• Provide technical data for incident investigations to identify root causes of batch failures.
• Prepare SLPs, SOPs, development reports, troubleshooting reports and GMP documents related to PD Lab.

Education

Bachelor's Degree in Chemical Engineering

Job description

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

1. Bachelors Degree in Chemical Engineering (B.E./B.Tech Chemical Engineering)

Experience

1. 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!

• We provide robust benefits and opportunities to foster personal and professional growth.

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).