241 Solid Orals Jobs - Page 10

Preferred candidate profile Qualification : B Pharma/M Pharma Year of Experience : 3 - 5 Yrs in shop floor management. Must have hands on experience in Compression/Coating Section. Having exposure of Audit facing internal and external party. Interested candidates may share profile at hr.plant@zuventus.com Job Location : Sikkim

Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement

Role & responsibilities 1. To ensure smooth third party Operation for all LL / TP location. 2. Responsible for third party process activities for OSD, solid oral dosage form. 3. To coordinate with LL / TP site for technical documents. 4. To be present and ensure production and packaging activities at LL/TP location. 5. To coordinate with PPMC / QA / QC / TP-LL location for smooth operation. 6. To prepare / review PIF (Product information form) and circulate with all stake holder, after approval timely share it with LL sites. 7. To ensure all activities to be done as per PIF. To maintain PIF file in soft and hard copy. 8. To maintain valid product and site license copy. 9. To prepare BMR / BPR for LL products and share it to LL site after final approval. 10. For ant changes / deviation ensure all should be handled through relevant QMS and its CAPA if any. 11. To ensure in-process at various stage of production and packaging and ensure its online documentation. 12. Before batch release ensure BMR and BPR and its relevant documents are reviewed and complied. 13. To ensure LL / TP site for readiness of audit. 14. To be present in process validation activities at LL/TP sites. 15. To coordinate with third party manufacturers for commercial products during technology transfer. To be present during technology transfer procedure at LL sites. 16. Identifying and executing continuous improvement opportunities at third party sites and communicate with TP and technical head. 17. To ensure products should be manufactured and packed and as per cGMPs, SOP's, relevant government regulations, and current industry standards. 18. To be part of audit team for RM vendor and LL-TP site. 19. Risk Management: • Identifying and assessing risks associated with third-party suppliers, including supply chain disruptions, quality issues, regulatory compliance and issues with CAPA. 20. Continuous Improvement: • Monitoring LL / TP site against key performance indicators (KPIs) and benchmarks. 21. Regulatory Compliance: • Ensuring that all third-party suppliers comply with relevant regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices, Good Distribution Practices (GDP), and other applicable regulations. Preferred candidate profile

Role & Responsibilities: Upkeep the laboratory with respect to cleaning and discipline. To follow the GLP regulations within the laboratory. To perform the method development, in process and stability activity of drug product as per the plan and priority. To record and maintain daily temperature and humidity record of laboratory in logbooks. To follow relevant safety and regulatory norms. To follow all time compliance to company policies and values. To prepare analytical data sheets as per current version of specification and Method of Analysis. To conduct project related analytical activities at Quality Control laboratory. To calibrate the instruments as per the plan or as and when required.

Role & responsibilities : 1 To perform Operation activity of equipment and instruments as per SOP. 2. To affix the status label to equipments, instruments and IPC at each and every processing stage 3. To operate the equipment in safe and effective manner for production processing. 4. To follow and adhere to GDP and cGMP practices. 5.Inspect equipment to identify any replacement, and repairs. 6. Ensure that the equipment are maintained in good and safe working condition. 7. To Perform regular equipment maintenance to ensure production capacity and quality. 8. Identify and report unsafe operations and near misses to supervisor immediately. 9. Perform the activity as per SOP and instruction given in BMR and BPR. 10. To perform balance Calibration and instrument calibration as per SOP Preferred candidate profile: 1. 02- 07 years of experience in Formulation Pharmaceutical Plant. 2. Relevant Experience in Pharma formulation plant. 3. Computer proficiency in MS Office, Excel, e-mail and internet function.

F&D of Solid, Liquid and Topical dosage forms End-to-end formulation & development of Herbal Nutraceutical products Tech transfer and coordination - manufacturing, trial batches & troubleshooting Stay updated on FDA guidelines & industry practices

Excellent job opportunity for OSD Production (Tablet Coating) @Unison Pharmaceuticals Pvt Ltd, Moraiya, Ahmedabad About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. You are invited to join one of the fastest growing pharma companies in India!! Experience: 2-7 years (OSD Production area - Tablet Coating) Designation: Officer / Sr. Officer Qualification: B.Pharma/M.Pharm No. of Openings : 02 Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills & experience, we encourage you to apply for this position. Kindly share updated resume on career@unisonpharmaceuticals.com Regards HR Team Unison Pharmaceuticals Pvt Ltd

We're looking for an experienced professional to lead and drive innovative formulation strategies from development to regulatory submissions. Experience: 16-18 Years(Group Lead) Location: Hyderabad(Dulapally) Key Responsibilities: -Lead end-to-end formulation development of OSD products for regulated and semi-regulated markets -Oversee pre-formulation, technology transfer, scale-up, and exhibit batch manufacturing -Collaborate cross-functionally with QA, QC, RA, Production, and Project Management -Ensure timely completion of development milestones and regulatory documentation (CTD/ACTD) -Mentor and guide a team of formulation scientists -Strong knowledge of ICH guidelines, regulatory expectations, and QbD approach -Proven leadership and team management capabilities -Experience in regulated markets (US/EU) preferred Interested candidates can apply share their profile at raghuveera.vutla@aizant.com

We are looking for a highly skilled and experienced Formulation Development Professional with 1113 years of experience in oral solid dosage forms (OSD). Key Responsibilities: -Lead formulation development projects from R&D to commercial scale. -Design and execute formulation strategies for ANDA/CTD/ACTD submissions. -Conduct literature search, pre-formulation studies, and prototype development. -Troubleshoot formulation and process-related challenges. -Work closely with cross-functional teams Regulatory, ARD, QA, QC, and Manufacturing. -Prepare technical documents, development reports, and support dossier preparation. -Manage technology transfer and scale-up activities to manufacturing units. -Ensure adherence to cGMP, ICH, and regulatory guidelines. -Experience in regulated markets (US, EU) is preferred. If you are passionate about innovation in formulation and want to be part of a growing team, we would love to connect! Apply now or send your CV to raghuveera.vutla@aizant.com

Roles and Responsibilities Develop new markets for pharmaceutical products through business development initiatives in ROW Market. Identify potential customers, build relationships, and negotiate deals to increase sales revenue. Conduct market research to stay updated on industry trends and competitor activity. Collaborate with cross-functional teams to launch new products in international markets. Manage export documentation and logistics for pharmaceuticals. Desired Candidate Profile 5-15 years of experience in International Business Development (IBD). Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of formulations, solid orals, tablets, and OSDs; knowledge of international market requirements preferred.

Responsibilities: Review IP landscape reports, non-infringement& FTO analysis Devise strategies for patent non infringement and invalidations Collaborate with R & D Scientist to explore design around strategies for P-IV & NCE products Conduct IP due diligence for product selection/ new opportunity identification. Support RA for patent certification, PIL clearances and declaration Monitor, review and manage ANDA litigations Conduct patentability searches, draft and file patent applications and manage prosecutions Ensure timely and effective task delivery through strategic planning prioritisation and execution.

Job Title:- Assistant / Deputy Manager – Regulatory Affairs (US Market) We are hiring Regulatory Affairs professional for the US Market. The candidate will be responsible for preparing, reviewing, and submitting ANDA

Sun Pharma is proud to announce the establishment of our world-class Technical Training Academies , a pioneering initiative in our industry. We invite passionate individuals with a zeal for coaching, and training to join us in this transformative journey. Seize this opportunity to enhance your career and shape the future of our organization. Joining our Technical Training Academies not only offers a chance to nurture your passion for coaching but also provides a platform to impact the industry at large. Its an opportunity to grow professionally while shaping the future of technical education in our field. Job Description: Location: Guwahati Technical Training Academy Head overseeing training initiatives across a cluster of pharmaceutical sites in India. As the Technical Training Academy Head, you will lead the development and execution of training programs across multiple pharmaceutical sites within a cluster. Your role is critical in enhancing employee skills, ensuring compliance, and driving operational excellence. Here are your key responsibilities: Understanding of the OSD Processes: In depth knowledge of OSD manufacturing methods Unit Operations Expertise: Knowledge & equipment proficiency in various unit operations related to OSD manufacturing - ranging from but not limited to - Granulation, Compression, Coating, Wurster Coating & Capsulation Strategic Planning : Collaborate with senior management to define the vision and strategy for technical training. Align training initiatives with business goals and industry best practices. Training Program Development : Design and curate training content for various roles (production, quality control, engineering, etc.). Develop comprehensive training modules covering technical skills, compliance, and safety. Training Delivery: Oversee training sessions, workshops, and webinars. Ensure effective knowledge transfer to employees at all levels. Quality and Compliance : Emphasize adherence to Good Manufacturing Practices (GMPs) and regulatory requirements. Monitor training effectiveness and address gaps. Resource Management : Allocate resources (trainers, facilities, materials) efficiently. Collaborate with site-specific training coordinators. Stakeholder Engagement : Work closely with HR, department heads, and site leaders. Understand specific training needs for each company. Continuous Improvement : Evaluate training outcomes and adjust programs as needed. Foster a culture of learning and skill development. Qualifications and Skills Experience : Proven track record in OSD manufacturing and unit operations, along with technical training or related roles. Leadership : Strong leadership skills to guide a team of trainers and coordinators. Communication : Excellent verbal and written communication. Industry Knowledge : Familiarity with pharmaceutical manufacturing processes. Adaptability : Ability to navigate diverse organizational cultures.

Hiring for Production Head for a leading Pharma Company near Chandigarh. Candidates with experience of working in MHRA site can apply

Job Description: Department: Formulation R&D Experience: 3 - 7 Yrs. Qualification: M.Sc / M.Pharma Skills: Should have prior experience and knowledge of development of Soft Gelatin Capsules Technical Documentations - BOM / MFR stability study guidelines , QMS knowledge of pharmaceutical development Technology Transfer to commercial site Should have knowledge of development of other dosage forms (Solid Orals / Liquids /Semi-solids) Good to have knowledge on Nutra / Ayurvedic Regulations

Qualification: Post-graduate in Pharmacy or Pharmaceutical Engineering Experience: 15 to 20 years in sterile manufacturing plant operations, with a minimum of 10 years in a leadership role and at least 7 years in a regulated sterile manufacturing environment. About The Company Fresenius Kabi Oncology Limited, a wholly owned subsidiary of Fresenius Kabi, is a leading player in the oncology generics market with a broad portfolio that includes injectables, cytotoxic, and APIs. Its state-of-the-art production facility in Baddi features dedicated units for cytotoxic and non-cytotoxic products, including liquid and lyophilized injectables. The facility is approved by global regulatory authorities such as EMA, ANVISA, and Health Canada, and its products are registered in over 30 countries. About The Role As Site Head of the Baddi facility, you will oversee and be responsible for all aspects of site manufacturing operations. This leadership role is pivotal in ensuring operational excellence, regulatory compliance, and strategic alignment with the global oncology supply chain. You will be responsible for driving performance, fostering a culture of continuous improvement, and leading a cross-functional team toward sustainable and efficient operations. The potential candidates should be result-driven, resilient, collaborative and empathetic. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous improvement in manufacturing efficiency, cost optimization, and product quality. Oversee the implementation of digitalisation, such as optical inspection and serialisation. People Management: Build and lead a high-performing cross-functional team. Foster a culture of accountability, safety, and innovation. Project Execution: Oversee capacity expansion, technology transfer, and commissioning of new lines (e.g., lyophilization, isolator-based filling systems). Stakeholder Engagement: Collaborate with corporate leadership, regulatory bodies, and cross-functional teams to align plant goals with organizational objectives.