Pune Maharashtra Pharmaceutical quality control Jobs – 110 Open Jobs Today

Research and Development Chemist
Deccan Nutraceuticals Pvt Ltd —Alandi, Maharashtra
- ₹3,00,000 - ₹3,50,000 a year
- Full-time
- Laboratory experience
- Research
- APIs
- Commuter assistance
- Food provided
Quick apply
8h
Manager - Governance, Risk & Compliance
ZS —Pune, Maharashtra
- Online application
- Computer Science
- Master's degree
- Bachelor's degree
- Work from home
Facilities Projects Lead
Corning —Pune, Maharashtra
- PMP
- Engineering
- Master's degree
Sr. Civil Engineer
Tata consulting engineers —Pune, Maharashtra
- Engineering
- Master's degree
- Project management
3d
Operations Manager
RSquareSoft Technologies —Pune, Maharashtra
- Full-time
- AWS
- Project management
- Presentation skills
Quick apply
Support Function - Stores
Tata consulting engineers —Pune, Maharashtra
- Engineering
- Master's degree
- Project management
Senior Planning Engineer-E4-Planning-PMO
Tata consulting engineers —Pune, Maharashtra
- Microsoft Excel
- PMP
- Engineering
Chemist
MITCON Consultancy & Engineering Services —Shivajinagar, Pune, Maharashtra
- Email
- Laboratory experience
- Master's degree
- Communication skills
Site Manager - Mechanical
Tata consulting engineers —Pune, Maharashtra
- Engineering
- Project management
- Bachelor's degree
Quality Management System
SailPoint —Pune, Maharashtra
- Full-time
- Salesforce
- English
- AWS
Survey Engineer
Tata consulting engineers —Pune, Maharashtra
- AutoCAD
- Civil engineering
- Engineering
11d
Application Engineer III
Johnson Controls —Pune, Maharashtra
- Full-time
- Programmable logic controllers
- Bachelor's degree
- HVAC
- Paid sick time
7h
Associate Director, Evidence Synthesis
EVERSANA —Pune, Maharashtra
- Full-time
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Sr. Automation Engineer
ENRIVET Technologies Pvt Ltd. —Pune, Maharashtra
- ₹35,000 - ₹60,000 a month
- Full-time
- Java
- Programmable logic controllers
- Bachelor's degree
- Cell phone reimbursement
Quick apply
2d
Pharmacist
Ruby Ailcare Services Pvt Ltd —Pimpri-Chinchwad, Maharashtra
- ₹15,000 - ₹25,000 a month
- Full-time
- Anatomy knowledge
- Bachelor's degree
- Patient care
Quick apply
5d
Purchase Manager
MatchLab Talent —Pune, Maharashtra
- ₹4,20,000 a year
- Full-time
- Microsoft Excel
- Programmable logic controllers
- Electrical experience
Quick apply
Transition Manager
Cencora —Pune, Maharashtra
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Discipline Head - Mechanical
Tata consulting engineers —Pune, Maharashtra
- Engineering
- Project management
- Bachelor's degree
Safety Officer-C1-Safety-Construction Engineering
Tata consulting engineers —Pune, Maharashtra
- Engineering
- Project management
- Bachelor's degree
Senior IT Delivery Manager - Life Sciences/Pharmaceuticals
EPAM Systems, Inc. —Pune, Maharashtra
- Agile
- IT
- Leadership
- Health insurance
- Paid time off

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Research and Development Chemist

Deccan Nutraceuticals Pvt Ltd
Alandi, Maharashtra

Quick apply

Job details

Full-time
₹3,00,000 - ₹3,50,000 a year
8 hours ago

Benefits

Provident Fund
Commuter assistance
Food provided

Qualifications

Gas chromatography
Laboratory experience
ISO 9001
Research
APIs
Communication skills

Full job description

JOB DESCRIPTION R&D – Regulatory Documentation & Technical Support1.

Job Purpose

To manage and support the preparation, review, compilation, and maintenance of technical and regulatory documentation for pharmaceutical/API development and manufacturing activities, ensuring scientific accuracy, data integrity, traceability, and regulatory compliance.

2. Key Responsibilities

Prepare, review, and coordinate technical/regulatory documents for DMF, CEP, and customer/regulatory submissions.
Coordinate with R&D, Analytical, Production, QA, QC, RA, and external laboratories/consultants for technical data collection and reconciliation.
Review process, analytical, and development information for consistency across regulatory documents.
Maintain document version control, references, change history, and supporting evidence.
Support responses to regulatory/customer queries and technical clarifications.
Ensure confidential handling of proprietary process and analytical information.

3. DMF Filing Support

Prepare and compile technical information for Drug Master File (DMF) submissions.
Support documentation related to manufacturing process, process controls, specifications, analytical procedures, validation/verification, and stability.
Compile and review process flow diagrams, batch information, raw material/KSM information, and critical process parameters.
Coordinate impurity, residual solvent, elemental impurity, and mutagenic/genotoxic impurity assessments.
Maintain supporting documents, certificates, analytical reports, references, and DMF amendment records.
Cross-check data between development reports, specifications, analytical reports, and regulatory submissions.

4. CEP Documentation Support

Coordinate preparation and compilation of technical documents for CEP applications, renewals, and updates.
Support compilation of manufacturing process, specifications, analytical methods, impurity profile, and stability information.
Review CEP technical packages for consistency with approved manufacturing and analytical information.
Track commitments, variations/updates, and supporting documentation.

5. Technical & Scientific Documentation

Prepare, review, and maintain Route of Synthesis (ROS), reaction schemes, process descriptions, quantities, conditions, work-up, and isolation details.
Prepare/review risk assessments covering process risks, impurities, residual solvents, elemental impurities, and mutagenic/genotoxic impurities.
Develop and maintain impurity profiles, including process-related, degradation, specified/unspecified, and carry-over impurities.
Prepare/review characterization reports using HPLC, GC, LC-MS/MS, NMR, FT-IR, DSC, TGA, XRD, UV, and elemental analysis, as applicable.
Coordinate structure elucidation of unknown/potential impurities and intermediates.
Compile process development reports covering optimization, parameter justification, yield/purity improvement, and scale-up studies.

6. Impurity & Risk Assessment

Evaluate potential impurities from starting materials, reagents, catalysts, solvents, intermediates, and process conditions.
Prepare/review impurity fate, purge, and carry-over assessments.
Support ICH M7, Q3C, and Q3D related assessments.
Establish scientific justifications for proposed limits and specifications using analytical data, process capability, and applicable guidelines.

7. Analytical & Characterization Data Review

Review chromatographic and spectroscopic data for technical and regulatory documentation.
Coordinate analytical testing and interpretation of unknown impurities and intermediates.
Review analytical method suitability, system suitability, impurity reporting, detection/quantitation limits, and specifications.
Ensure characterization data are linked to the proposed chemical structure and manufacturing stage.

8. Regulatory Compliance & Documentation Control

Maintain awareness of applicable ICH, pharmacopoeial, and regulatory requirements for APIs.
Ensure documents are scientifically justified, consistent, traceable, and supported by source data.
Maintain regulatory document master lists, pending actions, commitments, and document status.
Support responses to deficiencies, technical questions, and customer questionnaires.

9. Cross-Functional Coordination

Work closely with R&D, QA, QC, Production, Engineering, RA, Supply Chain, and external testing agencies.
Coordinate collection of specifications, batch records, analytical reports, certificates, and technical documents.
Participate in technical meetings related to regulatory observations, process changes, and documentation gaps.

10. Required Knowledge & Skills

Strong knowledge of Organic Chemistry/API chemistry and pharmaceutical process development.
Working knowledge of DMF and CEP documentation requirements.
Good understanding of ROS, impurity profiles, risk assessments, and characterization reports.
Understanding of ICH guidelines, pharmacopoeial requirements, and API regulatory expectations.
Ability to interpret analytical data and prepare scientifically sound justifications.
Strong technical writing, documentation, review, coordination, and communication skills.

11. Key Deliverables

Accurate and submission-ready DMF/CEP technical documentation.
Updated ROS and process development documentation.
Complete impurity profiles, risk assessments, and impurity fate/purge assessments.
Comprehensive characterization and structure-elucidation reports.
Timely responses to regulatory/customer technical queries.
Controlled and traceable regulatory document packages.

12. Performance Expectations

Deliver technically accurate, complete, traceable, and timely documentation while maintaining confidentiality and ensuring alignment between R&D source data, quality documents, and regulatory submission requirements.

13. Document Control

Department: R&D / Regulatory Documentation
Position: R&D – Regulatory Documentation & Technical Support
Document Type: Job Description
Version: 01

Pay: ₹300,000.00 - ₹350,000.00 per year

Benefits:

Commuter assistance
Food provided
Provident Fund

Work Location: In person

Quick apply

Refine Your Search

pharmaceutical quality control jobs in pune maharashtra

Research and Development Chemist

Manager - Governance, Risk & Compliance

Facilities Projects Lead

Sr. Civil Engineer

Operations Manager

Support Function - Stores

Senior Planning Engineer-E4-Planning-PMO

Chemist

Site Manager - Mechanical

Quality Management System

Survey Engineer

Application Engineer III

Associate Director, Evidence Synthesis

Sr. Automation Engineer

Pharmacist

Purchase Manager

Transition Manager

Discipline Head - Mechanical

Safety Officer-C1-Safety-Construction Engineering

Senior IT Delivery Manager - Life Sciences/Pharmaceuticals

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