9 Pellets Jobs

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, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

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 (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

Role & responsibilities 1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets. 2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures. 4) Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation. 5) Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries. 6) Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company.

Role & responsibilities Conduct competitive intelligence searches for understanding the competitive landscape for API pellets, granules technology and identifying opportunities for pellets business. Conduct patent searches for API pellets technology and identify blocking patents. Conduct patent infringement analysis of API pellets. Prepare report on global launch scenario for APIs through patent expiry status and regulatory exclusivity status. Tracking patent alerts for the in-house products, and studying the retrieved patents updates and communicating with R&D for feedback. Analyse customer patent queries on APIs/KSMs and draft responses to the queries.

Responsible for handling all production activities pertaining to Pellets or Granulation. Online documentation i.e. BMR, LOG BOOKS & OTHERS. To achieve the set targets & maintain qualitative & quantitative as well as cGMP aspects. Perks and benefits Accommodation & Transportation Mediclaim

Alembic Pharmaceuticals Ltd is looking for Executive-Manufacturing (Pelletisation) for its formulation Unit-I based at Panelav Role & responsibilities To ensure production as per approved Batch manufacturing record. To ensure House keeping and arrangement of shop floor as per cGMP requirement. On-line documentation, review and also handle E-TMS Software . Supervision of Production activities to ensure strict follow up of SOPs & BMR. Monitor, control and checking of in process checks during processing. Work allocation and optimum utilization of Manpower and handle shop floor activity. Responsible for GMP / Training to staff and operator in all department. Execution of Qualification activies as per qualification protocol. Experienced in Audit Faced of Regulated Market ( US , WHO and EU ) Essential Job Criteria Experience of wurster coating machine like Glatt FBE 250L,GFB 120 pro 500L,GFB 300 pro 1300L . With documentation Perks and benefits Best in Industry Interested candidates may share their resume to prodform@alembic.co.in with Subject line "PELLET"

Department - Production Designation - Production Associate Experience - 3 - 8 Years Salary Depends on interview Interview Mode - F2F at Ahmedabad. Salary Payroll - 3rd Party Payroll Education - 12th + ITI Section - Manufacturing (Granulation, Compression,Capsule, Pallet Coating) Primary Packing (Blister Packing - BQS, 230 XT , CAM, Sachet filling - Meshpack, Bottle & Bulk Packing - Countec , Anchor mark, ACE Tech) Secondary Packaging - (Cartonator - IC -105, Hi- cart, and CAM, Labelling and outserter - Counter , track & trace - ACG Inspection) Thanks & Regards, Darshana Whatsapp Mobile: +91-7486041356 Email: cv.naukri@evokehr.com

Responsible in Preventive maintenance, Breakdown and Shutdown maintenance as per chart schedule.Involved in Different areas of Field Instruments and Control System in Pellet Plant (straight Grade) like Induration Furnace, Balling Building etc.

WE ARE HIRING!! Role : Plant Head -[Pellets Pharma] Experience : 15+ Years Location : Sangareddy Salary : Upto 20 LPA Key Skills : Pellets End-End Manufacturing ,Plant Operations ,Production Planning ,Quality Assurance CONTACT ROSHINI HR 9502269355