Roles and Responsibilities Ensure compliance with GMP guidelines, BMRs, OSD requirements, and WHO standards for IPQA activities. Develop and implement effective quality control processes to ensure product quality and regulatory compliance. Conduct regular audits, inspections, and investigations to identify areas of improvement in batch manufacturing operations. Collaborate with cross-functional teams to resolve quality issues related to formulations, tablets, capsules, etc. Provide training on Good Manufacturing Practices (GMP) and other relevant regulations to employees.

Roles and Responsibilities 1. Preparing EHS legal requirements and registers. Ensuring on time EHS compliance to be followed for all the SG group locations. 2. Responsible for standardization and harmonization of EHS practices by preparation of polices and procedures in accordance with the ISO 4001, 45001, PSCI, BSRS (Business responsibility and social responsibility). 3. Working on ESG ratting platform (Ecovadis) by collecting and uploading evidence based nonfinancial management details including Environmental, Labor & Human Rights, Ethics and Sustainable Procurement. Ecovadis ratting benefits us manage our both upstream and downstream business. 4. Responsible for organising the safety committee meetings, Mock drills and ensure all the equipments such as Fire hydrant system, Fire Alarm System, Fire suppression System Etc to be in working condition at manufacturing locations. 5. Setting benchmarks for organization to understand best practices of peer organization to improve sustainability performance 6. Tracking & reporting of inspections, internals & external audits, conformance reviews including Pharmaceuticals in environmental (PiE), legal compliance, PSCI. 7. Preparing EHS budgeting for OPEX/CAPEX and ensuring budget is properly utilizing. 8. Responsible for conduct HSE Awareness Campaigns such as National safety Day, World Environment Day, Road Safety Day Etc. 9. Developing training need analysis by department wise and ensure to complete trainings.

Roles and Responsibilities Develop new business opportunities through strategic partnerships, alliances, and market research. Identify potential clients and develop targeted sales strategies to drive revenue growth. Build strong relationships with key decision-makers at client companies to understand their needs and preferences. Analyze market trends, competitor activity, and customer feedback to inform business development initiatives. Desired Candidate Profile Strong understanding of Contract Manufacturing (CDMO), Third Party Manufacturing (TPM), Domestic Marketing concepts. Proven track record of success in developing new business opportunities through effective relationship-building skills.

Roles and Responsibilities Develop new products by leading cross-functional teams through formulation development, process development, and scale-up. Collaborate with external partners (CROs) on OSD product development and registration dossiers preparation. Ensure compliance with regulatory requirements for solid oral products at CDSCO and DCGI. Manage budgets, resources, and timelines for R&D projects to achieve business objectives. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry with expertise in AR&D. Bachelor's degree in Pharmacy (B.Pharma) followed by Master's degree (M.Pharma). Strong understanding of formulation development, formulation research, Nutraceuticals, OSDs. Proven track record of successfully leading complex projects from ideation to launch.

Roles and Responsibilities Develop and implement new product ideas through CDSCO process. Oversee research and development projects from concept to commercialization. Collaborate with cross-functional teams to ensure successful project delivery. Ensure compliance with regulatory requirements (DCgi) and maintain high standards of quality control. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry, preferably in FR&D or similar role. B.Pharma degree in Any Specialization; M.Pharma preferred but not mandatory. Strong understanding of formulation development, formulations, nutraceuticals, OSDs, and solid orals.

Key Responsibilities: Testing and Analysis: Performing analytical tests on raw materials, in-process samples, and finished products using techniques like HPLC, GC, and titrations. Documentation and Reporting: Accurately recording and reporting test results, including any deviations from standards. Quality Assurance: Ensuring products meet established quality and safety standards, adhering to regulatory requirements and industry best practices. Collaboration: Working with other departments to resolve quality issues, implement corrective actions, and improve processes. Maintaining Equipment: Calibrating and maintaining laboratory equipment to ensure accurate and reliable results. Safety Compliance: Following safety procedures and using appropriate personal protective equipment when handling chemicals. Essential Skills and Qualifications: Education: A bachelor's degree in chemistry or a related field is typically required. Analytical Chemistry Skills: Proficiency in various analytical techniques and instrumentation. Attention to Detail: Meticulous and accurate in testing, documentation, and reporting. Problem-Solving: Ability to analyze and resolve quality issues. Communication: Effective communication and collaboration skills. Regulatory Compliance: Understanding of relevant regulations and industry standards.

Roles and Responsibilities Collaborate with cross-functional teams to identify market trends, competitor analysis, and customer needs to inform sales strategies. Provide backend support to the sales team by managing data entry, documentation, and reporting tasks efficiently. Ensure timely delivery of high-quality products to customers while maintaining excellent communication skills throughout the process. Identify areas for improvement in existing processes and implement changes to increase productivity and efficiency. Desired Candidate Profile 2-4 years of experience in pharmaceutical or nutraceutical industry with a focus on domestic marketing or CDMO services. Strong understanding of formulation development, OSD (Oral Solid Dose) manufacturing processes, and regulatory requirements. Excellent documentation skills with attention to detail; ability to manage multiple projects simultaneously under tight deadlines.

Key responsibilities include: Responsible for all Regulatory related activities includes Filing, Submission, responding to DCGI queries, Customer requirements, SUGAM portal registrations, Renewal of licenses, IP commission & CDTL requirements, etc. Responsible to get approvals for the submissions to CDSCO like New drug application, FDC application, Subsequent new drug application, Import license, Test license, etc. Responsible for FSSAI annual returns filing, FosCos online license modification. Responsible for handling PV related activities, which includes PSUR submission and reporting the adverse events of pharmaceutical products for case processing, reviewing & submitting the reports to regulatory authorities. Filing & Submissions: Responsible to prepare submissions to CDSCO like New drug application, Subsequent new drug application, etc. and ensures to respond the DCGI queries & SEC recommendations in timely manner to get permissions/approvals. Responsible to collect & review all the essential documents (API vendor documents, CMC documents, Administrative part, Clinical & Non-clinical data) from CFT for submission. Managing the queries raised by CDSCO against the submitted applications and responsible for addressing the queries & requirements from Indian Pharmacopeia Commission, Central/State Testing Laboratories, SEC committee, DCGI, CDSCO. Regulatory Compliance Management Supports in customer / regulatory complaints, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Ensures that customer / regulatory complaints are adequately handled, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Evaluates, reviews and approves product claim on labels and marketing collaterals in accordance to legal and regulatory requirements. Responsible to organize and archive all regulatory documents including NOC, Product license, NSQs data, AE reports, Drug office requests by co-ordination with site Co-ordinate with the Consultants and Customers on regulatory requirements for new products and major changes in existing products. Reviews proposed changes and its supportive information for completeness and accuracy while ensuring compliance with regulations set by the Central Drugs Standard Control Organization (CDSCO) Responsible for Monitoring of Compendial/ Pharmacopeial revisions or any addition of new monographs, which impacts our system and procedure and ensuring the changes implemented in License, Artwork labelling, specification, testing methods, BMR, BPR, MMR and procedures at all sites Communicate changes in regulatory directions, regulatory intelligence and competitive activities. Notify internally via RA notification as necessary within all relevant regulatory matters Pharmacovigilance Management Responsible for submission of Periodic Safety Update Reports (PSUR) to regulatory authority as a part of new product approval/regularization within stipulated timeline. Responsible for reporting the Adverse Event PV, follow up, coordination with site QA (in case of quality complaint) and provide investigation report to customers and getting the concurrence / approval from customer on investigation and closure. Co-ordinate with CRO for processing AE cases & responsible for reviewing and submitting the reports to regulatory authorities on time. Assisting in PV projects in compliance with customer agreement and local & global regulatory guidelines. Maintain and track all CAPAs & submitted reports related to pharmacovigilance. Ensure pharmacovigilance regulatory compliance with oversight, as needed. FSSAI (Food Safety & Standards Authority of India) To perform & ensures on-time FSSAI annual returns filing (Form ‘D’) periodically. Responsible for central FSSAI license modification by including addition of products time to time and other licensing activities like Free Sale Certificate. Ensures regulatory compliance related to registration of Food Business Operator through Food Safety Compliance System (FoSCoS), Food safety audit, etc. Quality management (NSQ): Co-ordinates with site team & ensure to fulfil the drugs control requirements (Documents/ Sample) of concern FDA/DCD/DTL by responding within stipulated timeline. Collaborate & Coordinate with internal team to make a strategic plan to respond the NSQ/Showcause cases.

Roles and Responsibilities Conduct microbiological testing and analysis of raw materials, in-process samples, finished products, and environmental monitoring to ensure compliance with regulatory requirements. Develop, validate, and maintain microbiology protocols for water systems, disinfection processes, and media preparation. Collaborate with cross-functional teams to investigate out-of-specification (OOS) results and implement corrective actions. Ensure timely reporting of test results to relevant stakeholders and maintain accurate records according to cGMP guidelines. Participate in audits and inspections by providing documentation support. Desired Candidate Profile 10-15 years of experience in a pharmaceutical industry as a Microbiologist or equivalent role. Strong knowledge of MLT Method Validation, Water System Validation, Residual Efficacy Method Validation, Disinfectant Validation, Qualification of Biological Indicators, Media Self Life Validation, Autoclave Validation. Experience with microbial analysis techniques such as plate counting and identification methods.