Job Summary
We are seeking an experienced analytical development scientist who can execute analytical activity based on priorities and established timelines provide timely analytical delivery for stability testing test method development/validation method transfers and other related requests from Research & Development (R&D) or formulation development.
Roles & Responsibilities
- Conduct Literature survey and prepare analytical strategy for assigned projects & Should have minimum understanding of DMF and test methods of drug substance etc.
- Perform analytical method development of Viscosity PSD GSD Assay RS preservative content residual solvents rheology IVRT etc
- Conducting of method validation and method development. Preparation of new specifications/STPs and COAs. Integration inputs from QA QC and RA members.
- Execution of method feasibility studies for compendia procedures of excipients/API/FP
- You will be responsible for analytical methods and process compliance as per quality assurance requirement.
- Perform calibration or performance verification of analytical equipment; Maintain & standardize reference or working standards; Check for the availability and validity of the Impurities.
- Perform the assigned day to day routine analysis of development stability samples scale-up PE batches.
- Execute assigned analytical activities as per defined procedures document the data and send the respective record of analysis of to group leader for the review and release IN ORDER TO provide the approved results to formulation team.
- Co-ordinate with other departments (CFTs) for procurement analytical method transfer activities specification finalization etc.
- Perform method transfers to plant QC customers or Third party labs for projects and support at the time of exhibit/submission batch execution.
- Adhere to the safety guidelines applicable ISMS guidelines SOPs equipment usage and maintenance procedures.
- Conducting studies at external CRO labs to manage peak workloads or when internal capabilities are not available. Providing technical support to CRO labs for smooth execution of studies.
Qualifications :
Education Qualification - MSc Chemistry M Pharm Chemistry
Minimum experience required- 8 12 years of experience in analytical development department and must have worked on nutritional product portfolio.
Skill Attributes
Technical Skills
Technical expertise related to chemistry analytical techniques stability study assessment and advanced research technologies
Efficient in MS Office Word/Excel/PowerPoint functionalities
Ability to interact with external labs and 3rd party manufacturing site labs to support product development team.
Ability to understand analytical methods defined by global and local bodies
Ability to resolve analytical issue associated with different product matrix.
Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC) Bureau of Indian Standards (BIS) etc.
Excellent knowledge of Good Laboratory Practices (GLP) Quality systems Standard Operating Procedures latest regulatory trends and Global regulations as appropriate
Data review interpretation of analytical data and accurate documentation of laboratory investigations.
Behavioural Skills
Systematic approach and strategic thinking
Possess excellent interpersonal skills communication coordination and time-management skills
Excellent oral/written communication and articulation skills
Ability to prioritize work and change focus quickly
Additional Information :
About the Department
Global Generics India
Global Generics India business journey began in 1986. In the last three decades we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently we rank among the top 5 in oncology anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities collaborations innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market.
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 Work :
No
Employment Type :
Full-time
Job Summary We are seeking an experienced analytical development scientist who can execute analytical activity based on priorities and established timelines provide timely analytical delivery for stability testing test method development/validation method transfers and other related requests from Re...
Job Summary
We are seeking an experienced analytical development scientist who can execute analytical activity based on priorities and established timelines provide timely analytical delivery for stability testing test method development/validation method transfers and other related requests from Research & Development (R&D) or formulation development.
Roles & Responsibilities
- Conduct Literature survey and prepare analytical strategy for assigned projects & Should have minimum understanding of DMF and test methods of drug substance etc.
- Perform analytical method development of Viscosity PSD GSD Assay RS preservative content residual solvents rheology IVRT etc
- Conducting of method validation and method development. Preparation of new specifications/STPs and COAs. Integration inputs from QA QC and RA members.
- Execution of method feasibility studies for compendia procedures of excipients/API/FP
- You will be responsible for analytical methods and process compliance as per quality assurance requirement.
- Perform calibration or performance verification of analytical equipment; Maintain & standardize reference or working standards; Check for the availability and validity of the Impurities.
- Perform the assigned day to day routine analysis of development stability samples scale-up PE batches.
- Execute assigned analytical activities as per defined procedures document the data and send the respective record of analysis of to group leader for the review and release IN ORDER TO provide the approved results to formulation team.
- Co-ordinate with other departments (CFTs) for procurement analytical method transfer activities specification finalization etc.
- Perform method transfers to plant QC customers or Third party labs for projects and support at the time of exhibit/submission batch execution.
- Adhere to the safety guidelines applicable ISMS guidelines SOPs equipment usage and maintenance procedures.
- Conducting studies at external CRO labs to manage peak workloads or when internal capabilities are not available. Providing technical support to CRO labs for smooth execution of studies.
Qualifications :
Education Qualification - MSc Chemistry M Pharm Chemistry
Minimum experience required- 8 12 years of experience in analytical development department and must have worked on nutritional product portfolio.
Skill Attributes
Technical Skills
Technical expertise related to chemistry analytical techniques stability study assessment and advanced research technologies
Efficient in MS Office Word/Excel/PowerPoint functionalities
Ability to interact with external labs and 3rd party manufacturing site labs to support product development team.
Ability to understand analytical methods defined by global and local bodies
Ability to resolve analytical issue associated with different product matrix.
Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC) Bureau of Indian Standards (BIS) etc.
Excellent knowledge of Good Laboratory Practices (GLP) Quality systems Standard Operating Procedures latest regulatory trends and Global regulations as appropriate
Data review interpretation of analytical data and accurate documentation of laboratory investigations.
Behavioural Skills
Systematic approach and strategic thinking
Possess excellent interpersonal skills communication coordination and time-management skills
Excellent oral/written communication and articulation skills
Ability to prioritize work and change focus quickly
Additional Information :
About the Department
Global Generics India
Global Generics India business journey began in 1986. In the last three decades we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently we rank among the top 5 in oncology anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities collaborations innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market.
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 Work :
No
Employment Type :
Full-time
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