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 RESPONSIBILITES
To provide support for execution and monitoring of trial, scale up and exhibit batches.
To prepare new product documents like material requirement sheet, batch manufacturing record, bill of material, risk assessment reports, contamination reports, sampling protocol, reports, exhibit batch manufacturing record and exhibit protocols and reports etc.
To prepare new product documents like sampling protocol and trial batch reports investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
To provide the regulatory response.
To send samples of trial / exhibit batches to formulation and development department.
To conduct training of protocols for batch execution.
To prepare site transfer documents and provide support during site transfer activities of the products.
To monitor the scale up batch/characterization batch and process qualification batches if required.
To share process knowledge to cross functional departments through presentation for smooth technology transfer whenever required.
To prepare investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
To prepare site transfer documents and provide support during site transfer activities of the products.
To prepare and evaluate product history and process parameters for technical remediation and improvement of product robustness.
To prepare investigation report/Justification report, additional activity protocol, regulatory evaluation etc.
To monitor the scale up batch/characterization batch and process qualification batches.
To prepare site transfer documents and provide support during site transfer activities of the products.
To prepare and submit the investigation reports for OOS, OOT and any failure for exhibit/validation/commercial batch manufacturing and during stability testing.
To prepare product containment approach and risk assessment for new product.
To prepare and arrange placebo for quality control testing if required.
To participate in various regulatory audits to support the plant.
Travel Estimate
Job Requirements
Educational Qualification
M.Pharma
Experience
Tenure: 2-5 Years
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).