Analytical Scientist

Job Summary

We are seeking an experienced scientist in analytical development who can plan and execute Method development and method validations. Knowledge in EM countries regulatory requirements including China & RUSSIA and knowledge in OSD dosage forms. Planning and execution of DPDM studies. Impurity evaluation studies for China Market filing. Updating spec and STPs of API FP and Excipients as per China ChP Compliance. Evaluation of lead country data for EM filings.

Roles & Responsibilities

• Evaluating lead country data and understanding the additional requirements to cater the individual country requirements. Planning and execution of analytical work. Conducting of method validation and method development. Prepare the new specifications and COAs. Integration inputs from QA QC and RA members. Preparing the risk assessment and mitigation plans.
• Planning and execution of method validations studies at plant required for different Emerging markets filings like China and Russia.
• Planning and execution of Dissolution profiles studies required for different Emerging markets filings.
• Impurity evaluation studies for China Market filing. Updating spec and STPs of API FP and Excipients as per China ChP Compliance
• Support to plant for investigation of OOS/OOT of EM products and resolve technical issues during execution of method validations and method transfers
• 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.
• Addressing prefiling queries from local and country RA  and  Closure of open points for EM Filings before the first deficiency communication from agency
•  You need to manage communication with stakeholders such as project leaders product development analytical teams and other business partners
• You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization
• You need to coordinate and follow up with external labs including training of their staff.
•  You will need to review of analytical data for accuracy compliance to quality requirements and completeness e.g. lab notebooks raw data system entries etc.
•  You will have to review of technical documents such as analytical reports method transfer /method validation protocols reports etc.
•  You will have to participate in handling and resolution of laboratory nonconformances with related documentation
•  You will be responsible for analytical methods and process compliance as per quality assurance requirement.

Qualifications :

Education Qualification MSc Chemistry M. Pharm
 
Minimum experience required6 9 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 timemanagement skills
Ability to independently handle teams
Excellent oral/written communication and articulation skills
Passion for people development
Ability to prioritize work and change focus quickly
Ability to delegate effectively

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 fastgrowing organisation with doubledigit growth and significant market share in domestic markets. Currently we rank among the top 5 in oncology antiallergy 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 !/ 

Remote Work :

No

Employment Type :

Fulltime