Team Member MSAT

Job Summary
We are seeking a dynamic and experienced person in Process Development/TT/MSAT to execute and monitor Confirmatory batch/ Trial batch/Scale up batch Exhibit batch/Prevalidation Validation batch/ Hold time batches & placebo batches by applying various engineering concepts during optimization and scale up.

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 Prevalidation & validation Batches on time.
• You will be responsible to prepare documents required for confirmatory batches/exhibit batches/ Prevalidation & validation Batches at plant. Perform Scale Up correlations for all unit operations from lab scale to plant scale. And provide control strategy for Prevalidation & validation Batches on Exhibit Batches based results.
• You will be responsible to prepare and review of the following documents like MFR PIS Sampling plan Master production record for Confirmatory batch/ Trial batch/Scale up batch Exhibit batch/Prevalidation 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 protocols 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: Masters in pharmacy

Minimum work experience: 37 years of experience in Process/TT/MSAT

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 problemsolving abilities.
• Performance oriented and good at building leveraging relationship.
• Ability to work collaboratively with own team and crossfunctional teams.
• Committed to Learning & Coaching the team. 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at !/ 

Remote Work :

No

Employment Type :

Fulltime