Roles and Responsibilities To participate and prepare/ review Computer System Validation and IT-QMS documentation To implement automation at site in coordination with IT, CSV, and user departments To implement software at site i.e. Labware LIMS, SAP, e-QMS, e-DMS, e-LMS, Minitab, e-BMR, Lab-solution, Empower etc. To perform / participate in qualification / periodic qualifications of software at site To prepare compliance documents preparation against observations related to computer systems To participate / perform self-inspections / internal audits at site To prepare SOPs in Quality Assurance Department To involve in Regulatory audits/customer audits for the compliance of Software & IT systems at site. To participate in qualifications of IPC/ SCADA, PLC, HMI system based equipment. To participate in qualifications/calibration of system connected / standalone instruments in laboratory. To perform GAP assessment of computerized system with respect to regulatory and current requirements in GMP To perform and review Data Backup, Verification and Restoration in GxP systems. To perform / review Preventive Maintenance of GxP system software. Skills & Knowledge Required in Candidate Sound knowledge in automation / Software implementation in the pharmaceutical industry Management of GxP automation activities and compliance at site. Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines & GAMP guidelines Well-versed with EU Annex 11 / 21 CFT Part 11 guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any in software implemented at site Preference if any The candidate is required to be present at the site by JULY 2025.
Role & responsibilities Experience: 9-14 years Specialization: Injectable Drug Formulation & Development Key Responsibilities: 1. Formulation Development: Lead the design and optimization of injectable drug formulations, ensuring stability, efficacy, and manufacturability. 2. Pre-Formulation Studies: Conduct compatibility assessments, stability testing, and excipient selection to enhance product quality. 3. Scale-Up & Technology Transfer: Oversee successful scale-up from lab-scale development to pilot and commercial manufacturing, ensuring reproducibility. 4. Sterile Manufacturing Expertise: Manage aspects of sterile formulation processes, including aseptic techniques, lyophilization, and parenteral drug delivery innovations. 5. Regulatory Documentation: Prepare and review CMC documentation for regulatory submissions, ensuring alignment with global health authority requirements (FDA, EMA, etc.). 6. Process Development & Optimization: Implement Quality by Design (QbD) and Design of Experiments (DoE) principles to refine injectable formulation strategies. 7. Cross-Functional Collaboration: Work closely with analytical, manufacturing, and regulatory teams to ensure seamless product development. 8. Troubleshooting & Problem-Solving: Address formulation challenges related to stability, compatibility, and manufacturing scale-up. 9. Innovation in Drug Delivery: Explore novel injectable delivery mechanisms, including depot injections, nanoparticle-based formulations, and biopharmaceuticals. 10. Leadership & Mentorship: Guide junior scientists, fostering innovation and technical excellence in formulation research. Qualifications: PhD/Masters in Pharmaceutical Sciences Extensive experience in sterile injectable formulation development with a strong track record of successful product launches. Expertise in aseptic processing, lyophilization, and excipient compatibility for injectables. Strong knowledge of scale-up processes, technology transfer, and industrial manufacturing practices. Proven ability to develop and optimize parenteral drug formulations, ensuring quality and regulatory compliance. Experience with regulatory pathways, and ANDA submissions. Understanding of bio pharmaceutical characterization for injectable products. Preferred candidate profile Candidate with exp of Pre-Formulation Studies and research Candidate with experience of successful scale-up from lab-scale development to pilot and commercial manufacturing, ensuring reproducibility candidate with Sterile Manufacturing Expertise. candidate with experience in Innovation in Drug Delivery: novel injectable delivery mechanisms, including depot injections, nanoparticle-based formulations, and biopharmaceuticals.
Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage with at least 4 years of experience in Peptides Key Responsibilities: 1. Lead formulation development for OSD products, including tablets, capsules, and granules. 2. Develop and optimize stable peptide formulations for OSD applications. 3. Conduct pre-formulation studies, compatibility assessments, and stability testing for peptide-based formulations. 4. Innovate in drug delivery strategies, ensuring enhanced bioavailability and release kinetics for peptide-based OSD formulations. 5. Work closely with analytical teams to characterize formulations using advanced techniques. 6. Oversee scale-up activities, ensuring successful transition from laboratory to pilot and commercial-scale production. 7. Manage technology transfer processes across manufacturing sites to ensure formulation integrity and reproducibility. 8. Prepare and review regulatory documentation, including CMC sections for global submissions. 9. Ensure compliance with GMP standards and regulatory guidelines for peptide drug formulation. 10. Utilize QbD and DoE principles for formulation optimization and process development. 11. Provide scientific leadership and mentorship to junior scientists within the formulation team. Qualifications: PhD/Masters in Pharmaceutical Sciences, or industrial Pharmacy Extensive experience in peptide formulation and oral solid dosage technologies. Strong expertise in excipient selection, stability enhancement, and formulation optimization. Understanding of global regulatory requirements, including expertise in preparing regulatory submissions and ensuring compliance with CMC guidelines. Ability to drive innovation in peptide formulation strategies and drug delivery systems. Preferred candidate profile OSD Experience at least 4 years of experience in peptides Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.
Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage Key Responsibilities: 1. Develop and optimize formulations for OSD drug products. 2. Conduct pre-formulation studies, compatibility assessments, and stability testing. 3. Lead formulation development for OSD products, including tablets, capsules, and granules. 4. Design and optimize OSD formulations, ensuring stability and efficacy. 5. Work closely with manufacturing teams for scale-up and technology transfer of OSD formulations. 6. Ensure compliance with regulatory guidelines and GMP standards. 7. Innovate in OSD drug delivery systems and formulation strategies. 8. Develop regulatory-compliant documentation for submission. Qualifications: PhD/Masters in Pharmaceutical Sciences. Significant experience formulation development and OSD technologies. Strong understanding of regulatory requirements for OSD products. Proficiency in QbD , DoE , and process optimization. Preferred candidate profile 1. Experience of compliance with regulatory guidelines and GMP standard 2. Hands on experience of Pre -formulation studies , compatibility Assessment , stability Testing
Role & responsibilities Experience: 9-14 years Specialization: 14 years of experience in Peptides Key Responsibilities: 1 Design and develop formulations for peptide-based drugs, ensuring stability, efficacy, and optimal bioavailability. 2. Conduct research on novel excipients and innovative drug delivery mechanisms tailored for peptide formulations. 3. Lead scale-up and technology transfer of peptide formulations from lab-scale development to commercial production. 4. Coordinate with analytical teams to perform in-depth characterization studies, including stability profiling and compatibility assessments. 5. Ensure regulatory compliance in formulation strategies, preparing CMC documentation for global regulatory submissions. 6. Optimize formulation processes using QbD and DoE approaches to enhance efficiency and quality. 7. Collaborate with manufacturing and production teams to ensure seamless formulation execution at large-scale levels. 8. Conduct pharmacokinetic and bioavailability studies to refine peptide drug delivery strategies. 9. Lead troubleshooting efforts related to formulation challenges, ensuring robust and scalable peptide drug development. 10. Provide technical leadership, mentoring junior scientists, and fostering innovation in peptide drug formulation. Qualifications: Extensive experience in peptide formulation and drug delivery systems. Expertise in stability studies, compatibility assessments, and formulation troubleshooting. Strong understanding of peptide pharmacokinetics, bioavailability enhancement, and absorption mechanisms. Experience with process development, scale-up, and technology transfer for peptide-based formulations. Knowledge of regulatory pathways, GMP compliance, and preparation of CMC documentation. Ability to develop innovative formulation strategies for improved therapeutic performance of peptide drugs. Proficiency in QbD and DoE methodologies to optimize formulation development processes. Preferred candidate profile Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.
Role & responsibilities Experience: 3-6 years Specialization: soft gel Key Responsibilities: Formulation Development : Design and optimize Softgel formulations for pharmaceutical and nutraceutical applications. Process Optimization: Conduct proof-of-concept studies, scale-up trials, and technology transfers. Regulatory Compliance: Ensure formulations meet ICH, FDA, and GMP guidelines. Analytical Coordination: Work with analytical teams to develop and validate testing methods. Troubleshooting: Address formulation challenges related to solubility, stability, and encapsulation. Documentation: Maintain accurate records, prepare technical reports, and contribute to regulatory submissions. Collaboration: Work with manufacturing, quality assurance, and regulatory teams to ensure seamless product development. Qualifications: Education: Masters degree (M. Pharm / industrial Pharmaceutics) or equivalent in Pharmaceutical Sciences Experience: 3 to 6 years in Softgel formulation R&D. Technical Expertise: Strong knowledge of gelatine-based and alternative encapsulation technologies. Regulatory Knowledge: Familiarity with ICH guidelines, GMP, and regulatory requirements. Analytical Skills: Ability to interpret analytical data and troubleshoot formulation issues. Communication: Strong technical writing and presentation skills. Preferred candidate profile Experience in Soft Gel
Althera Laboratories India private Limited is a leading OSD (Oral Solid Dosage) manufacturing company committed to developing and delivering innovative pharmaceutical products. We are seeking a highly motivated and experienced Clinical Project Manager to lead and oversee clinical trials for our drug development pipeline. Role & responsibilities Develop and execute comprehensive clinical project plans, timelines, and budgets in alignment with company objectives and regulatory requirements. Oversee all aspects of clinical trial conduct, including protocol development, site selection, investigator initiation, patient recruitment, data management, and safety monitoring. Prepare and present clinical study reports, regulatory submissions, and other relevant documentation. Ensure adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and other relevant regulatory standards. Collaborate effectively with cross-functional teams, including R&D, regulatory affairs, quality assurance, and medical affairs, to achieve project milestones. Build and maintain strong relationships with key stakeholders, including investigators, CROs, and regulatory authorities. Monitor and manage project timelines, budgets, and resources effectively. Identify and mitigate project risks proactively. Proficiency in clinical trial management software and systems. Required Qualifications: M. Pharma/Ph.D Min. 8 to 12 years of experience in clinical project management within the pharmaceutical industry. In-depth knowledge of EU regulatory requirements for drug development and clinical trials Strong understanding of clinical research methodologies and statistical principles. Proactively manage project risks, develop mitigation strategies, and communicate effectively to project teams and management. Strong leadership and interpersonal skills with the ability to build and motivate cross-functional teams. Preferred Qualifications: - Experience in OSD product development and clinical trials. Knowledge of global regulatory requirements.
MIS Preparation and Presentation for the manufacturing site Cost Management CAPEX/OPEX management of the plant Account Payable/receivable Vendor Payment & Bank reconciliation. Maintain records of vouchers, invoices, vendor payments, etc. Ensuring compliance with accounting and tax laws. Book-keeping - Preparation and finalization of Accounts related works in dedicated book-keeping software. Desired Candidate Profile 8-12 years of proven experience with the pant activities. Proficiency in accounting software, Microsoft Office, Candidate should be from Pharma (OSD) working experience. Good communication skill. Should be willing to work in Mysore Plant.
We are seeking a Manager Quality Assurance (CMO) to oversee and manage the quality assurance activities at third-party manufacturing sites (CMOs). This role is critical to ensuring that contract manufacturers comply with regulatory requirements, company quality standards, and GMP guidelines. The ideal candidate will have a strong background in quality systems, audits, and pharmaceutical manufacturing (formulations). Role & responsibilities Develop, manage and improve quality systems and procedures to ensure compliance with regulatory standards in support of cGxP activities. Perform the gape assessment on regulatory guidelines and tracking of actions and its effective implementation at CMO/Althera affiliates. Responsible for review, approval and close out of change controls, deviations, CAPA, incident reports and any other quality related documents. Review and approvals of analytical and formulation development related master documents, protocols, and reports. Responsible for review and approvals of master documents (BMRs, BPRs, MFR, PVPs, PVRs etc.) and Protocols (Validation, Qualification, Cleaning, stability etc.) Overseas and monitoring of day-to-day activities in analytical development and formulation development (RnD site). Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates. Perform vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits. Conduct periodic audit of CMOs and participate in the qualification programme as and when needed. Planning and conducting of self-inspection, preparation of schedule, execution with cross functional departments, and verifying the self-inspection compliance report for correctness and completion. Oversee, support and coordinate with the CMO/Althera affiliates on batches manufacturing and testing sites. Coordination with the European QA / RA team on supplying necessary quality documents as and when required. Responsible for CAPA monitoring, implementation, and its effectiveness at respective sites. Participate in the investigations at the manufacturing sites where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations. Handling of customer complaints and to co-ordinate with the respective manufacturing sites to get the investigation done on timely manner with appropriate root causes and CAPA. Implementation of new softwares at contract manufacturing sites and sound knowledge on computer system validation. Coordinate with CMOs in any regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment. Ensure quality / technical agreements with contract manufacturing organization (CMOs) are available and updated within timeline and its compliance. Review of NIRA and EIRA for the Althera products. Preferred candidate profile Should have CMO experience with 12-15 years Should be M.Pharma Should have good experience in handling QA team at CMO with a strong background in managing CMO operations . Experience in formulations (OSD) , depending on product line. In-depth knowledge of GMP regulations , regulatory guidelines , and quality systems .
To lead and manage the end-to-end procurement process for Active Pharmaceutical Ingredients (API), excipients, and packing materials required for the commercial formulation plant, ensuring uninterrupted production, cost efficiency, and full compliance with regulatory and quality standards. Roles and Responsibilities 1. Strategic Procurement Planning: Develop and execute procurement strategies aligned with production schedules and business goals. Plan material requirements proactively in coordination with Production Planning and Control (PPC) to ensure zero stock-outs. 2. Vendor Development & Management: Identify, qualify, and onboard reliable vendors for APIs, excipients, and packing materials. Build long-term supplier relationships and negotiate competitive terms and conditions. Monitor vendor performance on delivery, quality, and compliance. 3. Cost Optimization & Budget Control: Drive cost-saving initiatives while maintaining quality and regulatory compliance. Conduct market analysis and benchmarking to support strategic sourcing. Track procurement budgets and ensure cost-effective purchasing decisions. 4. Regulatory & Quality Compliance: Ensure all procured materials meet quality, cGMP, and regulatory requirements. Coordinate with QA/QC and Regulatory Affairs for documentation, approvals and vendor audits. Maintain compliance for all procurement-related documentation and systems. 5. Operational Coordination: Collaborate with cross-functional teams including Production, QA/QC, Stores and Finance. Manage timely issuance and follow-up of Purchase Orders in SAP/ERP systems. Handle material deviations, rejections, and supplier non-conformances efficiently. 6. MIS & Reporting: Prepare and maintain procurement reports, supplier evaluation metrics and material status reports. Monitor inventory levels, lead times, and stock ageing for continuous improvement. Candidate required from Formulation (Pharma) only. Perks and Benefits Best in the Industry
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