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3.0 - 10.0 years
15 - 19 Lacs
Ahmedabad
Work from Office
Understanding of product development related activities of all injectable dosage forms for regulated market. Exposure to injectable dosage form which includes exposure in development of complex injectable products like suspension-based formulation, liposomal formulations, Polymer based products etc. Experienced in preparation and review of product development report, MFR, stability protocol and other study protocols and SOP etc. Basic understanding of implementation of QbD principles for formulation and development (QTPP/CQA/CPP/CMA, risk assessment and control strategy etc.) Effective co-ordination with different departments like regulatory affairs, manufacturing warehouse, quality assurance, quality control and engineering etc. for execution of scale up and exhibit batches.
Posted 1 month ago
2.0 - 5.0 years
3 - 4 Lacs
Thane, Ambernath
Work from Office
Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.
Posted 2 months ago
8.0 - 13.0 years
4 - 7 Lacs
Neemrana
Work from Office
Job Profile : Manufacturing Chemist Location : Neermarna, Rajasthan Experience: Minimum 10 years of experience into same Pharmaceutical industry Salary : UP-to 7.5 Lpa ( Negotiable for good candidate ) Notice period : Immediate Role & responsibilities Develop and optimize pharmaceutical formulations. Over see and maintain consistent,high-quality production batches. Ensurecompliancewithregulatoryandqualitystandardsacrossmanufacturingprocesses. Preferred candidate profile Educational Qualification : B.Pharma/M.Pharma. Industry Experience: Minimum 10 years of relevant experience in the pharmaceutical formulation industry. Regulatory Approval: Must be approved in the manufacturing of Tablets,Capsules,Dry Syrups, Liquid Orals, and External Preparations in Beta-Lactam and Non-Beta-Lactam categories (or Non-Beta-Lactam only). Technical Expertise: In-depth knowledge of manufacturing a wide range of: Tablets :Uncoated,film-coated,sugar-coated,enteric-coated, dispersible,and sustained-release formulations. Liquid Orals : Syrups and suspensions. o Capsules&Dry Syrups. External Preparations :Creams,ointments,and tube-based formulations. Proficientinpreparing: MasterFormulationRecords(MFRs) BatchManufacturingRecords(BMRs) StandardOperatingProcedures(SOPs) ProcessValidationandCalibrationDocuments Strongunderstandingofpharmaceuticalmanufacturingsoftwareandgeneralcomputer applications. Interested can connect on 7217623080/hr.msservicesggn@gmail.com
Posted 2 months ago
5.0 - 7.0 years
7 - 9 Lacs
Hosur
Work from Office
Job Summary : As a Quality Assurance (QA) professional with a qualification in MSc Chemistry, the primary role revolves around ensuring adherence to established quality and regulatory standards. The responsibilities cover a wide range of quality-related tasks, documentation management, and process validation activities in alignment with ISO and cGMP standards. Key Responsibilities: 1 Review and Implementation of ISO 9001 standards, Quality Management System Compliance, cGMP standards, ISO 14001, Halal & HACCP standards 2 Preparation of Certificate of Analysis, Good Receiving Note and other related documents in process QA checks. 3 Review of Purchase order coordination for dispatch activities 4 To ensure the dispatch activities and clearance 5 Coordination for finished products 6 To verify the LMR, BPR and analytical records 7 Preparation of cleaning validation protocols and reports 8 Prepartion of process validation protocols and reports 9 Preparation/revision of MFR for all new existing products based on changes 10 Review and approval of Lot Manufacturing Record and Batch Packing Record 11 Preparation of blending protocols and reports 12 Document Management Control
Posted 2 months ago
0.0 years
8 - 9 Lacs
Baddi
Work from Office
Ensure scientific assessmentinto the Manufacturability of the product for a robust process developmentduring new product introductions, product site transfers and processvalidation. Technical Support during process optimization activities related to ProductTransfer ProcessValidations. Technical input andknowledge sharing with team and Cross functional team (CFT). Root Cause Analysis, Statistical evaluationsand Trouble Shooting of existing commercial as well as site transfer products. Improving process capabilities, yields androbustness. Prepare, Review and Approval of technical documents like MFR, PORM, BMR,BPR, Risk assessment , protocols and reports for Trial batch, Hold timestudy, Stability study, Process validation, Exhibit or submission batchdocumentation, alternate vendor development and side transfer project. Support documentation teamin order to deliver end to end documents from development batches (exhibit) tocommercial lifecycle management. Q
Posted 2 months ago
4.0 - 5.0 years
5 - 6 Lacs
Rangpo
Work from Office
Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com
Posted 2 months ago
12.0 - 20.0 years
12 - 16 Lacs
Aurangabad
Work from Office
We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad . Details of the position are mentioned below: Role & responsibilities: Literature search/study and to prepare development trials strategies. Pre formulation study execution. Market/Innovator/reference product characterization. Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies. Execution of process optimization/scale-up batches. Technology transfer activities at site. Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements. Co-ordination with production, other relevant cross-functional departments/teams. Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market. Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc. Preferred candidate profile : Educational Qualification: M. Pharm Experience: 12 - 20 Years of relevant experience in a leading Pharma Company. Good Communication & Presentation skills Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile number: 98202 34987
Posted 2 months ago
2 - 5 years
2 - 4 Lacs
Surendranagar
Work from Office
Job Title: QA Executive Department: Quality Assurance Location: Surendra Nagar , Gujarat Qualification: B.Pharm / M.Pharm / M.Sc Experience: 2 - 5 years in pharma QA with QMS Key Responsibilities: Implement and maintain Quality Management System (QMS) as per GMP guidelines. Handle deviations, change controls, CAPA, and SOP documentation. Support internal audits and regulatory inspections. Prepare, review, and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, and processes. Coordinate with cross-functional teams for validation and compliance activities. Ensure GMP documentation, data integrity, and timely closures. Skills Required: Strong knowledge of QMS, validation, and regulatory requirements. Good documentation and communication skills. Team player with attention to detail. Interested candidate please join us!
Posted 2 months ago
6 - 11 years
5 - 12 Lacs
Bharuch, Dahej, Ankleshwar
Work from Office
Technology Transfer professional to support seamless scale-up and integration of new products/processes from the production floor. The role bridges development and manufacturing, ensuring process understanding, compliance, and efficiency.
Posted 2 months ago
2 - 5 years
3 - 5 Lacs
Vadodara
Work from Office
KEY RESPONSIBILITIES: Following are the job responsibilities for Development Quality Assurance. Review of analytical documents like Residual solvent statement, Risk assessment for Elemental impurities etc. generated during the product development at Injectable R&D. Review & Approval of Analytical method (including Extractables and Leachables) validation protocols & Reports (Including review of Raw Data). Review of all the protocol based studies related to Extractable and Leachables. Review of Protocol and Report related to Peptide Characterization. Review and approval of R&D specifications, GTPs and other documents. Review and approval of formulation and analytical study protocols and reports. (Equipment Qualification, Submission documents like Justification for specification, Residual Solvent Assessment and Elemental Impurities, Compatibility studies). Review of the logbook and register for completeness and correction as per Good documentation practices and cGMP norms. Review of Filter Validation Study Protocols and Reports. Review & Approval of Master Formula Record (MFR). Review of Product Development Report (PDR). Participation in incidences, investigation & CAPA review and approval. Review method validation protocols and reports for products to be executed at contract manufacturing or research organization. Review & approval of Computer system validation documents as per the defined procedure Review of IT related documents with respect to respective SOP
Posted 2 months ago
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