We are having opeings in the below departments and should be expertise in the area. Department - Experience - No of openings - Positions OSD Manufacturing - 2 to 9 Yrs - 40 No's - Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Executive OSD & Inj Packing - 2 to 9 Yrs - 40 No's - Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Executive Warehouse - 2 to 9 Yrs - 45 No's - Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Executive IPQA Inj & OSD - 2 to 9 Yrs - 30 Nos - Officer / Sr. Officer / Executive / Sr. Executive Engineering - 2 to 7 Yrs - 45 No's - Technician / Sr. Technician / Officer / Sr. Officer / Executive
Role & responsibilities • All Types of Consumables for SEZ Unit Chemicals, consumables • Inter Unit Transfers • QC Chemicals, Production Consumables Micro Biology Consumables, EHS & Eng maintenance • Send Enquiry for all vendors for Chemicals /Consumables materials • RFQ Comparisons for Consumables, Raw water, oil, & Gases • Materials delivery follow up as per PPIC-plant requirement • PO Creation for Chemicals / Consumables. PO Approvals Follow up with Approver. Approved PO's send to concern Vendors • New Vendor Code Creation & MPN Code creation • MPN Follow-up with DQA & PDD • Documents follow-up with vendors for VQ & PQ process. • Advance payment Request (DP), Advance & Overdue payments follow-up with Accounts Team. Preferred candidate profile * Preferred from Formulation Background * M.sc Freshers Also Eligible to Apply. Perks and benefits
Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits
Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits
Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits
Role & responsibilities Responsible for handling of CMO projects of solid orals and injectable products from project initiation to commercial launches Responsible for handling of site transfer projects that and will be SPOC for all projects that will be executed at CMO Responsible for preparation of project tracker and monitoring of project timelines as per set milestones Responsible for handling of activities related to new product launches from CMO sites for US/EU & Canada territories Should be able to coordinate with QP labs for method transfer activities and commercial releases Should be able to coordinate between customers, internal cross functional teams and CMO partners for project activities. Responsible for handling of customer communications of commercial projects Can share your profile to karthik.kumar@vbshilpa.com Preferred candidate profile Need profiles from Pharma Industry Perks and benefits
Job Description : M.pharm(Pharmaceutics) Patent Search and Patent Report preparation FTO analysis and timely updates of patent reports Additional experience in portfolio selection (new product identification) Hands on experience with patent databases like Scifinder, general search databases like WIPO, USPTO, Espacenet Qualification : - M.pharm(Pharmaceutics)
Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits
Role & responsibilities Required for Quality Control(Formulations) Quality Control(QC)- Need 1 to 5 years of experience. *Analysis of Finished Product & Stability *GLP and LIMS, Documentation Preferred candidate profile Perks and benefits
Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits
Role & responsibilities Analytical method development (AMD): Should have the experience to develop Assay, related substances, Dissolution, In-vitro permeation test (IVPT), Physical tests (Cold flow, Shear, Tack, Release linear force and Peel adhesion). Analytical method validations and method transfer: Oversee and ensure successful completion of validation as per regulatory standards; ensure successful analytical method transfer to receiving lab. Stability analysis: To carry out stability analysis and preparation of stability compilation data. Coordinating with cross functional teams for smooth flow of the teams. Review analytical documents. Calibration of analytical instruments. Should have the sound knowledge to troubleshoot issues related to analytical method development.
Role & responsibilities National Sales Manager Preferred candidate profile Ortho,Gastro and MS. Adept at fostering strong relationships with specialists. Demonstrated successin launching and promoting pharmaceutical products. Strong communication skills and a keenlearner, consistently adapting to contemporary industry trends. Overseeing sales operations Specializing in catering to diverse medical specialties such as Ortho, Rheumatology and CP Leading a robust team Mainly engaged with Orthopedic and CPs and GPs Played a pivotal role in driving business growth, with a particular emphasis on achieving substantial results in the Orthopedic segment
Role & responsibilities * Production planning and FG dispatches. * Material & Inventory management and control. * Shortage & risk tracking. * Ensuring material availability as per production schedule. * Handling SAP, MS Excel and coordinating with QA/QC/Production/Warehouse departments for timelines. * Prepare daily, weekly and monthly production planning reports. * Follow up with vendors and procurement teams to ensure timely availability of materials
Role & responsibilities Provide comprehensive medical and scientific expertise and oversight for clinical trials, ensuring study integrity and participant safety. Review and contribute medical input to study protocols, ensuring clinical feasibility, scientific rigor, and compliance with regulatory requirements and guidelines. Ensure strict adherence to clinical trial protocols through continuous monitoring and proactive management of ongoing studies. Prepare, critically review, and approve essential clinical trial documents across all phases, including Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Clinical Study Reports (CSR), Safety Management Plans, Medical Management Plans, Case Report Forms (CRF), Investigator Brochures (IB), and related documentation. Evaluate and manage clinical safety data by reviewing adverse events (AEs), serious adverse events (SAEs), and other safety-related information, contributing to timely risk assessments and patient protection. Support the development of medical writing materials, scientific presentations, and publications to disseminate clinical study findings effectively. Collaborate closely with cross-functional internal teams, clinical investigators, regulatory authorities, and relevant external stakeholders to facilitate efficient study conduct and regulatory compliance. Prepare and review regulatory submission documents, including Scientific Advice requests, Pre-IND packages, Controlled Correspondence, and other essential regulatory communications to support product development and approval processes Preferred candidate profile Medical degree (MBBS, MD or equivalent) with relevant clinical experience in various therapeutic areas. Strong understanding of clinical trial design, and execution. Ability to critically evaluate medical and scientific data. Excellent communication skills. Experience in pharmaceutical industry clinical research is preferred. Familiarity with safety data management and pharmacovigilance is favored
Role & responsibilities CMC and Labelling: Preparation of ANDAs in eCTD format for various type of formulations Review of the technical documents such as Specifications, BMR, MFC, Able to work on All type of CTD section write-ups Hands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS) Through knowledge on ICH guidances Should able to handle Module -I related activities Able to review Drug substance DMF and should prepare a due diligence eCTD Related activities: Complete knowledge on eCTD related publishing activities Practical knowledge on PDF attributes such as book marking, intra inter hyper ink, file destination TOC’s etc., should adhere to FDA published latest guidance Creation of eCTD sequence File names per requirement Uploading the documents for new sequence and knowledge on Append, add replace attributes for LCM products External hyperlinking from the server Should able to handle the errors that encounters during publishing Practical knowledge on inbuilt and other approved validator (Lorenz ) Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits
FIND ON MAP