Role & responsibilities Candidate should have through knowledge on regulatory guidance, literature search applicable for sterile formulation developments. Responsible for development and execution of complex injectable, suspension, emulsion / ophthalmic formulations solution, suspension, emulsion for regulated market. Should be responsible for review of trials and stability data throughout product development. Candidate should have hands on experience in transfer of technology from R&D to plant / GMP scale. Candidate should be responsible drafting and review of documents like MFC, MPC, BMR/BPR, Stability protocols, specific study protocols / reports, product development report, change controls, item code generations etc.. Responsible for all formulation/ process related CMC documents drafting and review which will be part of regulatory filings. Responsible for execution of process optimization batches, exhibit batches at manufacturing site. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs. Responsible for maintaining lab equipments and ensure lab practices as per defined SOP. Preferred candidate profile Specialization : OSD/Sterile/Ophthalmic for ROW Emerging & Regulated Market. Experience : 2-7 Years Position : Officer / Sr.Officer/Executive Qualification : M.Pharm. Contact : rajiv.farkade@indoco.com and gauri.deo@indoco.com
Role & responsibilities 1. . Dossier Compilation 2. Query Responses 3. Commercial Document Review 4. Post-Approval Changes 5. Change Control Review Preferred candidate profile Markets Handled : Europe ROW ( Malaysia, Singapore, Philippines, Zimbabwe, Zambia, Mexico, UAE, Oman, Qatar, Kuwait, Ukraine, Uzbekistan, Kyrgyzstan, Azerbaijan, Botswana, Mauritius, Tanzania, Kenya and FWA)
As a Product Manager in the field of life sciences, your role will involve providing clinical placement and marketing direction for new molecules and conceptual product launches. You will be responsible for life cycle management, formulation concepts, branding, packaging, and communication strategies for innovative products. Your creative and editorial skills will be crucial in executing concepts and direction for specific brands, segments, and projects. Key Responsibilities: - Identify opportunities and develop a complete product development portfolio for long-range planning, including the evaluation of innovative formulation and packaging concepts. - Conduct insight transfer and strategy articulation sessions with marketing teams for both existing and new products. - Utilize your expertise in scientific and medical details, creativity, data analysis, and interpretation to make sound decisions. - Demonstrate leadership qualities with a high creative and strategic quotient, along with a visionary outlook and strong business acumen. - Maintain a high degree of confidentiality in handling assigned work. Qualifications Required: - Graduate or Post Graduate in life sciences (e.g., B. Pharm, M. Pharm, B. Sc. in Microbiology or Biology), MBBS, or BAMS with additional management qualifications. - 8-10 years of relevant experience in product management. - Sound knowledge of the products and markets you have dealt with in prior assignments. In this role, you will play a critical part in driving the success of innovative products and shaping the future of the company's offerings. Your ability to combine scientific expertise with strategic vision will be key to achieving our business objectives.,
Role & responsibilities Preparing and reviewing of written procedures (MFR, BPR, ECR, SOP) for the production of intermediates or APIs as per laid down quality system standards & pre- approved documents. Production of API and intermediates according to approved BPR. Ensuring the cleaning of equipment and production facility according to approved ECR. Evaluation of changes in process, equipment and facilities for impact on product quality. Review of batch production record & cleaning records and ensuring that these are completed and signed. Preparation and review of qualification protocol & report. Review of validation protocol & report, and quality system documents and records. Perform the necessary calibration and qualification activity for equipment, facilities and maintaining the records. Ensuring the production facility and equipments are clean and appropriate disinfected. Report and investigation the deviations, nonconformity with appropriate CAPA. Carry out the investigation for nonconformity like deviation, OOS, OOT, complaint, breakdown etc. Initiate of corrective and preventive action as and when required. Ensure that the processes are carried out in an effective manner so as to ensure expected output is achieved. Implementation of technology transfer for new products. Implementation of quality management system and SOPs. Ensure GMP, good housekeeping and safety in manufacturing area. Controlling and monitoring the quality of products. Controlling and monitoring on inventory. Monitor the compliance for internal and external audit observations. Preferred candidate profile Ready to work at Navi Mumbai (Rabale) Should be only from Pharma API background Ready to work in shifts For Executive : 5 to 8 years For Manager : 12 - 15 years
Role & responsibilities Market Experience : Australia / New Zealand / South Africa / EU / UK/ WHO Preparation, compilation, review, and submission of new product registrations, and duplicate marketing authorizations for assigned projects. Due diligence for product registration documents and compilation of requirement matrix. Compilation, review, and submission of documents and timely co-ordination with Agencies until approval from national authority. Preparation and compilation, review, and submission of responses of deficiencies received from Agency and MAH. Review and finalization of operational and technical documents and assessment protocols and reports. Handling of Document management system for review and archival of specification. Preparation and Review of SmPC, Patient information and Labelling. Review and finalization of artworks. Coordination and follow up, communication of regulatory update with cross functional team. Liaising with MAHs and Clients for different documents, variation and new product registration. Maintenance and timely updation of Regulatory Database for approved products and providing information to CFT/MAH/Clients/BD about regulatory submission and approvals via Product Master Form. Evaluation of impact assessment of Change controls, Change Notifications, pharmacopoeia notification, CFT proposal etc. Technical and Regulatory support for Product launch and exhibit batches execution. Liaising / attending meeting with external stake holder/ affiliate for different documents, variation and new product registration and to keep track of the out-licensed/ in-licensed projects Literature search, gap assessment and feasibility evaluation for new product, extention applications and variations. Scientific advice and Co-ordination with the Agencies for the guidance related to new product development and variation activities. Coordination and communication, Tracking, RA review and Support for EU and UK Agency and Office bearer invoices for timely payment Preparation, maintenance and archival of tracking spreadsheets for monthly and annual developments (Monthly dashboards/Project tracker/ Nitrosamine status) Preferred candidate profile
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