
Manager - 2
1 day ago
Job Description Job Title CMC-IRA Job Grade G11B/G11A Function India Regulatory Affairs Location: Baroda Job Summary Review of CMC documents. Documents include but not limited to following: Drug Substance - Structural formula, molecular formula and relative molecular weight - General description of raw materials - Identification of critical steps in process and control - Flow diagram of manufacturing process - Description and characterization of drug substance - Physiochemical data: (Chemical name and structure, Empirical formula, Molecular weight) - Physical properties:- Description, Solubility, Rotation, Partition coefficient, Dissociation constant. - Analytical Data: Elemental analysis, Mass spectrum, NMR spectra, IR spectra, UV spectra, Polymorphic identification - Complete monograph specification and STP - Impurities (name, manufacturer) - Residual solvent/ other volatile impurities (OVI) estimation - Manufacturing process for drug substance - Validation of manufacturing process [assay method, impurity estimation method, residual solvent/other volatile impurities(OVI) estimation method] - Manufacturer(s) - Stability of drug substance - Tests and evaluation of packaging materials - Specifications of primary and secondary packing - Container closure system - Reference standards - Justification of specifications - Storage and shipping conditions of drug substance - Protocol of stability study, results and conclusions - Manufacturing process development - Selection and justification of critical steps - Filling procedure for the active ingredient, in-process controls - Stabilization of active ingredient Drug Product - Justification of final qualitative/quantitative formula - Manufacture of drug product - Description and composition of drug product - Description of manufacturing process - Protocol of stability study, results and conclusions - Stability of drug product - Tests and evaluation of packaging materials - Specifications of primary and secondary packing - Container closure system - Finished product specification and STP - Justification of specifications - Excipient compatibility study - Dissolution Study - In process quality control check and report - Certificate of analysis - Validation of analytical procedures - Forced degradation study - Process validation protocol and Report - Labeling - Details of equipment and facilities for production of drug product: master formula, batch record and set release documentation in respect of consistency batches - Description of batch identification system - Control of excipients (adjuvant, preservative, stabilizers and others) - Use of new adjuvants, preservatives, stabilizers and excipients Areas Of Responsibility - Checking of CMC documents. - Discussion with CFT for corrections - Co-ordination for finalized CMC documents from stakeholders - Review and approval of CCR - Compilation of CMC dossier for regulatory submission including query responses Travel Estimate Only if required Job Scope Internal Interactions (within the organization) Yes External Interactions (outside the organization) Yes, in case of CMO projects Geographical Scope Financial Accountability (cost/revenue with exclusive authority) Job Requirements Educational Qualification M. Pharma Specific Certification Experience 5-10 years Skill (Functional & Behavioural): Knowledge of CMC requirements/understanding of ICH quality guidelines
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Manager - 2
5 days ago
Vadodara, India SUN PHARMA Full timeJob Description Executive and Sr. Executive - Review all data and documents related to product registrations for various health authorities. - Compile registration dossiers for submission to various health authorities like China , Canada, Europe, Australia/New Zealand, Japan and Israel. - Prepare responses to deficiency letters received from various...
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Senior Manager
1 week ago
Vadodara, India SUN PHARMA Full timeJob Description Job Profile : This position requires effective communication, stakeholder management, risk identification, change management, issue resolution and presentation skills. - Manages project from PIF till filing in coordination with CFT comprising of Formulation, Analytical, Regulatory, Quality, API, MSTG, BD - Knowledge of PM tools (MS...
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Manager -2 MSTG
1 week ago
Vadodara, Gujarat, India Sun Pharma Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJob Title:Manager 2 – MSTG Non OralsBusiness Unit:R&D1 Regulatory AffairsJob GradeG11ALocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you enter the...
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Manager - 2 Biotechnology
3 weeks ago
Vadodara, India SUN PHARMA Full timeJob TitleManager 2 - Biotechnology Business UnitR&D1 Regulatory Affairs Job GradeG11A LocationBaroda At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun...
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Manager - 2 Biotechnology
13 hours ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob TitleManager 2 - BiotechnologyBusiness UnitR&D1 Regulatory AffairsJob GradeG11ALocationBarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma...
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Senior Executive
3 days ago
Vadodara, India SUN PHARMA Full timeJob Description Key Responsibilities: Analytical Method Development & Validation - Develop and validate robust HPLC methods for characterization and quantification of biological products (e.g., monoclonal antibodies, recombinant proteins). - Perform method optimization, robustness studies, and transfer protocols as per ICH guidelines. Routine & Stability...
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Manager -2 MSTG
1 week ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob TitleManager 2 – MSTG Non OralsBusiness UnitR&D1 Regulatory AffairsJob GradeG11ALocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you enter the Sun...
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Manager-2
1 week ago
Vadodara, India Sun Pharmaceutical Industries Ltd Full timeHandling of filter validation activities including review of PPQ form, filterability trial documents, filter validation protocol and report. - To keep track of filter validation activity. - To review risk assessment reports for extractable and leachable study. - Review of product development documents - Review of tech-transfer documents. - Review of...
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Manager 2- Formulation Development Non Orals
3 days ago
Vadodara, India SUN PHARMA Full timeJob Description Job Title Manager-2 - FR &D Non-Orals (Compliance group) Business Unit R&D1 Regulatory Affairs Job Grade G11A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create...
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Manager -2 Mstg
5 days ago
Vadodara, Gujarat, India Sun Pharmaceutical Industries Full timeJob Title Manager 2 - MSTG Non Orals Business Unit R D1 Regulatory Affairs Job Grade G11A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you...