Team Member MSAT

Good Health Can’t Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary

Roles & Responsibilities

• You will be responsible to demonstrate successful process scale up to ensure smooth execution of confirmatory & exhibit Batches on time.
• You will be responsible to demonstrate successful process scale up to ensure smooth execution of Pre-validation & validation Batches on time.
• You will be responsible to prepare documents required for confirmatory batches/exhibit batches/ Pre-validation & validation Batches at plant. Perform Scale Up correlations for all unit operations from lab scale to plant scale. And provide control strategy for Pre-validation & validation Batches on Exhibit Batches based results.
• You will be responsible to prepare and review of the following document’s like, MFR, PIS, Sampling plan, Master production record for Confirmatory batch/ Trial batch/Scale up batch, Exhibit batch/Pre-validation and Validation batch placebo batch but not limited to that.
• You will be responsible to analyse data and provide support in answering process related deficiencies ensuring on time response to regulatory agencies.
• You will be responsible to Prepare and review of the following protocols and reports like Hold time study protocol & report, Submission batch protocol & report, PPQ protocol & report, PORM, eMBRs, MI & BOM.
• You will be responsible to prepare and review of stability study protocol’s and reports based on the requirements.
• You will be responsible to prepare and review of tooling specification, Quality risk assessment & miscellaneous trial protocol, and reports
• Support in cleaning verification and validation activity.
• You will be responsible to coordinate with CFTs for timely completion of activities.
• You will be responsible to prepare of detailed investigation reports with appropriate recommendations and CAPA for Submission & validation batches
• You will be responsible to plan and carry out trials based on requirement to identify probably root causes.
• You will be responsible to Initiate change control for where ever required for execution of batches.
  

Qualifications

Educational qualification:

Skills & attributes:

Technical Skills

• Experience in the development/ scale up/ technology transfer of products in Solid dosage forms or technologies.
• Understanding of pharmaceutical process selection
• Ability to prepare technical protocols and reports.
• Experience in process Engineering and risk assessment approaches.
• Knowledge of ICH and other relevant guidelines.
• Familiarity and proficiency in using statistical software.
• Experience in Analytical Research and knowledge on interpretation of the data.

Behavioural Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Performance oriented and good at building, leveraging relationship.
• Ability to work collaboratively with own team and cross-functional teams.
• Committed to Learning & Coaching the team.
  

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered