Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because 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.
- Vacancy details:
- Department: Analytical scientist
- Qualification:B. Pharma (5-8 years), M. Pharma ( 2-5 Years), M. Sc. (5-8 Years)
- Experienced: 2-8 years
- Salary:₹Not Disclosed
Job Description: Greeting from Dr. Reddy’s Laboratories Ltd. .!!!!!
- Important Details :
- Location: Hyderabad
- Post of date :25/07/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job Description
AREAS OF RESPONSIBILITY (AOR) Header
Definition
IN ORDER TO, what results1Dossier filing support (FDF Model)
Identify the gaps in data requirements as per the filing country regulatory checklist.
Prepare the necessary documents required for filing specific to API plus Markets. (e.g., Specification, STP, validation documents etc.).
Connect with respective cross functional teams to collect the data required for the submission in order to successful filing of dossiers.
2Analytical method transfer Prepare the list of analytical requirements in advance in the identified technology transfer projects.
Provide onsite or off-site analytical support to partners to resolve technical issues and challenges for smooth Analytical method transfer.
Provide the guidance to PMO team member, for arranging the right standards to the partner.
3Deficiency support Prepare the responses for regulatory deficiencies at the earliest possible time.
Perform the experiments required to address the deficiencies.
Modify the Analytical documents as per the country or Regulatory agency requirement.
Collect the raw data and label as per regulatory requirement in order to address the deficiencies.4Technical Management
a. Provide the technical data / documents / information to address the queries related to analytical section.
b. Identify the technical gaps and alert the concerned stake holders in time to avoid the last-minute surprises and help to derive mitigation plans.
C. Build the relationship with cross functional team and keep updated with lead country analytical deficiencies.
D. Perform the experiments required to address the challenges raised by the partners which they had undergone during their execution5Support for Predeal assessment a. Collect the information related to Analytical, manufacturing, stability, packing, regulatory, commercial etc. to support the pre-deal evaluation.
b. Gather the data to address the customer queries raised during the deal discussions.
Qualifications
MINIMUM REQUIREMENTS
Education & Experience B. Pharma (5-8 years), M. Pharma ( 2-5 Years), M. Sc. (5-8 Years) Business Understanding In-depth understanding of the dossier filing requirements of API PLUS markets and technical knowledge for successful filing.
Knowledge Behavioral Skills: Chromatography and spectroscopy knowledge; Other chemical analysis experience.
Knowledge on ICH guide lines.
Communication skills,
Presentation skills,
Influencing skills and
Decision making skills
