DifGen Pharmaceuticals

Senior Research Associate

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  16 days ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, Telangana 500072
Position Type: Full Time
Job Shift: Day
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- - - - Responsible for reviewing all projects for packaging material and new development activities.
- - - - PIF evaluation and Literature Review for new products.
- - - - Review and Approval of RLD/Innovator packaging material analysis and characterization
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- - - reports.
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- - - - Review and Approval of trade dress and packaging Developments reports.
- - - - Proposing primary and secondary packaging materials for new products
- - - - Sourcing of packaging materials and vendor finalization .
- - - - Review and Approval of Specifications and STP for packaging materials.
- - - - Review and Approval of master packaging cards (MPC) .
- - - - Review and Approval of Bill of materials for packaging materials.
- - - - Review of CFT/CMO documents (BPR/IBPR/BMR).
- - - - Review and Approval of Threshold analysis reports and DHF documents (URS, DDP, Design
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- - - Input, Design Output, Design Verification, Design Validation, Design Review, Design transfer, etc.).
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- - - - Review and Approval of protocols for in-house and external lab testing for packaging
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- - - materials.
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- - - - Coordination with CFT teams and customers for smooth documentation .
- - - - Coordination with CMO for smooth execution of Scaleup and Exhibit batches.
- - - - Coordination with suppliers for layout/ change parts development .
- - - - Review and Approval of Change Controls for documentation .
- - - - Preparation of Packaging Development SOP's.
- - - - Preparation of bracketing sheets for container closure system and generation of protocol-
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- - - based packaging functionality studies and design qualification studies.
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UG/PGEducation Qualification: B. Pharmacy or M. Pharmacy

Experience: Minimum 5 years in relevant job profile.
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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