DifGen Pharmaceuticals

Team Leader

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  1 month ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
Salary Range: ₹1,200,000.00 - ₹1,500,000.00 Salary/year
Job Shift: Day
- Formulation R&D Documentation
- Prepare and maintain:
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- - Batch Manufacturing Records (BMRs)
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- - Batch Packaging Records (BPRs)
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- - Product Development Reports (PDRs)
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- - Technology Transfer documents
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- - Development protocols and reports
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- Ensure timely and accurate documentation of formulation trials, observations, and outcomes.
- Assist formulation scientists in preparing regulatory and technical documents.
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- - Cross-functional Coordination
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- - Liaise with QA, Regulatory Affairs, and Manufacturing Technology Transfer teams for timely documentation support.
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- - Track project documentation timelines and ensure timely delivery of required documents.
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- -  Documentation & Records Management
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- - Maintain indexing and archival of all R&D documents for easy retrieval and compliance.
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- - - Participate in internal and external audits and inspections by providing required documentation.
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- - - Maintain strict version control and ensure document traceability.
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- - Regulatory and Quality Compliance
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- - Ensure all R&D documentation adheres to GMP, GLP, ICH, and regulatory requirements.
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- - Analytical R&D Documentation
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- - Prepare and maintain:
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- - - Method development & validation protocols/reports
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- - - Analytical method transfer documents
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- - - Stability protocols and reports
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- - - Instrument calibration & maintenance logs
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- - - Raw data compilation and summaries
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- - Support analysts with proper documentation practices and adherence to data integrity requirements.
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M. Pharmacy or MSCM. Pharmacy or MSC candidate good documentation as well as communication skill.
DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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