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6.0 - 10.0 years
0 Lacs
karnataka
On-site
As a Senior Executive Technology Transfer at Bluefish Pharmaceuticals, you will contribute to the Technology Transfer Department function objectives. Reporting to the Senior Manager-Formulation Development, your responsibilities will include executing technology transfer, site transfer, alternate vendor development, and troubleshooting activities for tablets, capsules, and pellets. You will evaluate technical queries, address issues faced during commercial batches, and ensure regulatory compliance. Key Responsibilities: - Execute technology transfer, site transfer, alternate vendor development, life cycle management, and troubleshooting activities for tablets, capsules, and pellets. - Evalua...
Posted 2 weeks ago
5.0 - 7.0 years
5 - 7 Lacs
ahmedabad
Work from Office
Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (...
Posted 3 weeks ago
1.0 - 4.0 years
1 - 3 Lacs
vadodara
Work from Office
Job Description Line clearance in dispensing and production area. To perform in-process sampling, testing and document the observations. To handle IPQA activity in warehouse and production area. Review of BMR, process documents etc. APR Preparation. To ensure timely validation of production equipment w.r.t. process, cleaning and to collect samples for cleaning validation etc. To follow GMP and ensuring timely documentation of dispensing, manufacturing and packing activity. To identify problem areas in manufacturing and report to Head QA.
Posted 3 weeks ago
6.0 - 10.0 years
6 - 12 Lacs
vada
Work from Office
We are looking for a highly competent and experienced Senior Formulation & Development (F&D) Chemist with extensive hands-on exposure in the development of solid oral dosage forms, specifically tablets and pellets. Experience on Pellets is Must!! Office cab/shuttle Health insurance Leave encashment Gratuity Provident fund Job/soft skill training Annual bonus
Posted 3 weeks ago
8.0 - 10.0 years
10 - 12 Lacs
hyderabad
Work from Office
QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,
Posted 3 weeks ago
8.0 - 10.0 years
10 - 12 Lacs
patancheru, hyderabad
Work from Office
QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,
Posted 3 weeks ago
8.0 - 13.0 years
10 - 13 Lacs
bengaluru
Work from Office
Responsible for the development and dossier deliverable of genreic application for projects assigned with in the team for Europe ,Canada Australia. Preparation ,review and approval of test licenses Import license applications. Planning and procurement of RMPMs/ RLDs and inventory control at R&D for development. Preparation and review of RMPMs/Justification of Specifications/Cleaning validation report/Risk assessment report/ stability protocol/CDRs/Technology Transfer dossiers. Review of MFRs/BMRs/BPRs/PVPs/HTS, product specific questionnaire, Protocol; and report etc. for scale up and registration batches Timely and Appropriate Reponses for CMC and Bio deficiencies from regulatory agencies f...
Posted 1 month ago
8.0 - 13.0 years
7 - 13 Lacs
navi mumbai
Work from Office
Role & responsibilities 1. Development of stable, bioequivalent pellets dosage forms (IR/SR/DR/ER/MUMPS) 2. Efficient technology transfer of pellets projects from R&D to plant level. 3. Closely working with Plant team for trouble shooting of ongoing commercial pellets projects. 4. Oversee all aspects of pellets dosage forms including planning, execution, and innovation strategy. 5. Evaluate and implement new technologies for pellets product development. 6. Collaborate with internal teams and external partners for project success. Preferred candidate profile M. pharma
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
thane, maharashtra
On-site
As a Product Development Manager, you will be responsible for developing new products and optimizing existing formulations for various dosage forms such as Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS, etc. Your primary focus will be on regulated markets like the US, Europe, and ROW. Key Responsibilities: - Define project scope, activities, and timelines, and monitor progress to ensure timely completion. - Lead the development of new formulations by investigating API characteristics, safety, and compatibility with other ingredients, conducting necessary testing, and scaling up studies. - Identify resource requirements, including materials, manpower, and machinery, and utilize lit...
Posted 1 month ago
2.0 - 7.0 years
4 - 9 Lacs
hyderabad, medchal, gagillapur
Work from Office
Job Title: Wurster Operator Work Location: Gagillapur, Hyderabad Department: Production / Manufacturing Experience: 2 to 7 Years Qualification: ITI / Diploma (Mechanical/Electrical) or B.Sc. (Chemistry or related field) Job Description: We are looking for experienced professionals to join our Formulation manufacturing team as Wurster Operators . The ideal candidate should have hands-on experience in operating Wurster and other fluid bed equipment in a pharmaceutical setup. Key Responsibilities: Operate Wurster, Fluid Bed Coater (FBC), Fluid Bed Dryer (FBD), and Fluid Bed Equipment (FBE) as per batch manufacturing instructions. Monitor machine performance and take timely action to address any...
Posted 2 months ago
10.0 - 14.0 years
16 - 22 Lacs
hyderabad
Work from Office
Role & responsibilities Formulation Development (Solid Orals, Liquids, MUPS, Molten Mass, Roll Compaction) Technology Transfer & Scale Up. QbD & DoE Methodologies Regulatory Compliance (US, EU, Emerging Markets) Preferred candidate profile Leading Successful Technology Transfer of Multiple Site Transfer Products for US & EU Markets, Ensuring Zero Regulatory observations during Inspectoins.
Posted 2 months ago
2.0 - 6.0 years
2 - 6 Lacs
hyderabad
Work from Office
Roles Open: QA (QMS, Validations and AQA): Qualifications, Process/Cleaning Validation, QMS (Change Controls, Deviations, CAPA, Complaints, and OOS) RA (Regulatory Affairs): CTD Preparation/Review, Regulatory Queries, Tech Transfer Documents. Required Candidate profile QA Executive / Sr. Executive (QMS & Validations) AQA Executive / Sr. Executive (Analytical QA) RA Executive / Sr. Executive – Regulatory Affairs
Posted 2 months ago
6.0 - 8.0 years
7 - 10 Lacs
hyderabad
Work from Office
Role & responsibilities Formulation Development (Solid Orals, Liquids, MUPS, Molten Mass, Roll Compaction) Technology Transfer & Scale Up. QbD & DoE Methodologies Regulatory Compliance (US, EU, Emerging Markets) Preferred candidate profile Leading Successful Technology Transfer of Multiple Site Transfer Products for US & EU Markets, Ensuring Zero Regulatory observations during Inspectoins.
Posted 2 months ago
16.0 - 23.0 years
9 - 18 Lacs
kolkata, west bengal, india
On-site
Professional Summary: Dynamic and results-driven professional with Pan India experience in sales, marketing, and contract management within the steel sector, specifically in Sponge Iron, MS Billets, and Pellets. Expertise in B2B market development, distribution network expansion, depot and consignment agent management, tender participation, logistics coordination, stockyard operations, and commercial contract oversight. Proven ability to manage marketing teams, develop strategic sales plans, lead tendering processes, and optimize end-to-end supply chain activities. Key Responsibilities: Sales & Marketing Domestic (Steel Products) Handled Pan India domestic sales and marketing of Sponge Iron,...
Posted 2 months ago
5.0 - 10.0 years
6 - 8 Lacs
ahmedabad
Work from Office
Role & responsibilities Keep track of new inquiries from customers and add new customers for ROW, MENA, LATAM, ASEAN, EUROPE markets Generate new leads for customers from online platforms, website, exhibitions, etc Make promotional material, banners, stall design for exhibitions Attend exhibitions on behalf of the company Prepare and execute Annual promotional budget presentations for development of exports Preparing marketing literature, presentation, write ups for various products of the company as well as for the company Co-ordination with Artists for designing of various print promotional materials as well as online promotional material Promoting company as well as products on various on...
Posted 2 months ago
1.0 - 3.0 years
2 - 4 Lacs
Palghar
Work from Office
Key responsibilities include literature reviews, pre-formulation, pellet formulation, stability studies, process validation, technology transfer, troubleshooting, and maintaining documentation like QAQN, MFR, FPS, and logbooks. Perks and benefits Accommodation, Transportation and Mediclaim.
Posted 3 months ago
2.0 - 7.0 years
3 - 8 Lacs
Pune
Work from Office
Role & responsibilities Granulation Supervisor Responsibilities: Supervise the granulation process, ensuring compliance with Batch Manufacturing Records (BMR) and adherence to Good Manufacturing Practices (GMP) . Ensure effective process adherence, timely production, and achievement of department goals. Focus on yield improvement , identifying and implementing strategies to optimize production efficiency and minimize waste. Monitor and maintain granulation equipment, ensuring smooth operation and troubleshooting as needed. Collaborate with cross-functional teams to address any production or quality-related issues. Provide training and mentorship to junior staff, ensuring operational efficien...
Posted 3 months ago
3.0 - 7.0 years
0 Lacs
thane, maharashtra
On-site
About Rubicon Research: Rubicon Research Limited is a fast-growing pharmaceutical formulation company dedicated to delivering value to customers and investors through the development, manufacturing, and marketing of branded specialty and generic prescription pharmaceutical products in regulated markets. With a product portfolio of over 250 SKUs across more than 70 product families, Rubicon Research has established a strong presence in the US market through its subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. The company operates two US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development an...
Posted 3 months ago
13.0 - 15.0 years
13 - 15 Lacs
Visakhapatnam
Work from Office
Formulation - Research & Development - Pellets exp is must , Comply with GMP’s, SOP’s,regulatory documentation.,Develop Robust formulations & Evaluate patents and develop non-infringement strategiesScale up and optimization of manufacturing process.
Posted 3 months ago
4.0 - 6.0 years
2 - 4 Lacs
Nagpur
Work from Office
Job Description: We are looking for an experienced Officer to join our team at our pellet manufacturing facility in Nagpur. The ideal candidate will have 4–6 years of experience in manufacturing operations.
Posted 3 months ago
10.0 - 17.0 years
2 - 4 Lacs
Aurangabad
Work from Office
Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech T...
Posted 3 months ago
1.0 - 3.0 years
2 - 4 Lacs
Palghar
Work from Office
Responsible for handling all activities pertaining to Tablets & Capsules & Pellets Mfg. Responsible to handle the team to achieve the set targets & maintain qualitative & quantitative as well as cGMP aspects. Perks and benefits Accommodation & Transportation And Mediclaim
Posted 4 months ago
2.0 - 7.0 years
2 - 7 Lacs
Ahmedabad
Work from Office
Walk-in Interview for Zydus Lifesciences Ltd. Moraiya - Ahmedabad at Moraiya| 22nd June 2025 | We are recruiting for our Ahmedabad Units at Moraiya, Ahmedabad. Walk-in Interview Details Date : 22nd June 2025 Interview Location: Moraiya, Ahmedabad Timings: 9:00 am 3:00 pm Interview Venue: Zydus Lifesciences Limited, Moraiya Opp. Akshar industrial Park, Survey No.417,419&420, Sarkhej- Bavla N.H. No.8A, Village: Moraiya, Tal: Sanand, Dist: Ahmedabad- 382210, Gujarat, India Job Location: Ahmedabad Education Qualification: M.Sc. / M. Pharm / B. Pharm / B.sc /Diploma/ ITI Experience: 3 13 Years Production- OSD: Officer / Assistant manager : Tablet/ Capsule - Granulation, Compression, Coating, Insp...
Posted 4 months ago
8.0 - 13.0 years
10 - 13 Lacs
Bengaluru
Work from Office
Responsible for the development and dossier deliverable of genreic application for projects assigned with in the team for Europe ,Canada Australia. Preparation ,review and approval of test licenses Import license applications. Planning and procurement of RMPMs/ RLDs and inventory control at R&D for development. Preparation and review of RMPMs/Justification of Specifications/Cleaning validation report/Risk assessment report/ stability protocol/CDRs/Technology Transfer dossiers. Review of MFRs/BMRs/BPRs/PVPs/HTS, product specific questionnaire, Protocol; and report etc. for scale up and registration batches Timely and Appropriate Reponses for CMC and Bio deficiencies from regulatory agencies f...
Posted 4 months ago
6.0 - 8.0 years
7 - 9 Lacs
Ahmedabad
Work from Office
Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formu...
Posted 4 months ago
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