SHASUNMED LIFE SCIENCES PVT. LTD

[Exp: 2 to 5 years] We are looking for an experienced and detail-oriented professional to support downstream operations in a Bulk Manufacturing (BM) facility for small molecule API production. The role involves equipment handling, documentation, compliance, and coordination with cross-functional teams to ensure efficient and cGMP-compliant manufacturing processes. Key Responsibilities: · Facility readiness, monitoring, and routine maintenance; ensure operational efficiency of key equipment including mixing vessels, centrifuges, AGR, GLR, SSR. · Participate in shift operations to support continuous manufacturing activities for small molecule APIs. · Prepare, review, and maintain process-related documentation including MFRs, BPRs, SOPs, protocols, and other downstream process documents; ensure timely submission and closure. · Good understanding in chemical engineering concepts like Extraction, Distillation, TFF, Column chromatography, Centrifugation, Filtration, Drying · Manage Quality Management System (QMS) activities, including initiation and closure of change controls, deviations, and CAPAs related to bulk manufacturing. · Track and manage inventory of raw materials and consumables used in the manufacturing process. · Adhere to and promote safety protocols and proper use of PPE within the bulk manufacturing environment. · Support the scale-up and execution of development batches in coordination with R&D · Coordinate with the engineering team and external vendors to track and complete preventive maintenance and calibration activities for downstream equipment and instruments. · Ensure compliance with Good Documentation Practices (GDP) and cGMP standards in all facility and process operations. · Liaise with vendors for equipment and instrument qualification, troubleshooting, and resolution of technical issues related to downstream processes. · Collaborate with internal stakeholders and actively participate in technical and safety training to ensure seamless production operations. Preferred candidate profile · Expertise in handling aseptic operation and critical equipment’s in downstream process. · Ensure compliance with quality management systems. · Must have knowledge on GDP, GMP practices during batch operation in commercial campaign. · Must have work experience in manage the team Industry Type: Pharmaceutical & Life Sciences Department: Production, Manufacturing Employment Type: Full Time, Permanent Education: Diploma/B.Tech/MSc/ in Chemistry/Chemical Job Type: Full-time Pay: ₹10,000.00 - ₹25,000.00 per month Benefits: Provident Fund Ability to commute/relocate: Pondicherry, Puducherry: Reliably commute or planning to relocate before starting work (Required) Experience: Pharmaceutical: 3 years (Required) Life science: 3 years (Required) Analytical chemistry: 3 years (Required) Chemical engineering: 3 years (Required) Work Location: In person

Job Title: QC Manager– Analytical (10Years’ Experience) Industry: Biopharmaceutical Location: Puducherry Department: Quality Control – Analytical Reports To: QC Manager Job Summary: We are seeking a motivated and detail-oriented QC Analyst (Analytical) with 2 to 4 years of experience in a regulated pharmaceutical or biopharmaceutical QC laboratory. The role involves performing analytical testing of raw materials, in-process samples, and finished products in compliance with cGMP and regulatory requirements. Key Responsibilities: Perform routine and non-routine analytical testing of: Raw materials, intermediates, in-process, finished products, stability samples Water and cleaning validation samples (if applicable) Operate and calibrate analytical instruments such as: HPLC, GC, UV-Vis, FTIR, Karl Fischer, pH meter, Dissolution, etc. Prepare and review test records, logbooks, and related documentation as per GMP and data integrity standards. Conduct analysis as per pharmacopeial methods (USP, EP, IP, JP) Support in method validation/verification and equipment qualification activities. Review and interpret analytical results and escalate OOS/OOT results promptly. Maintain compliance with laboratory SOPs, GLP, and safety procedures. Participate in stability studies, trending data, and document control activities. Support investigations, deviations, and implementation of CAPAs related to QC analytical operations. Participate in internal and external audits and regulatory inspections. Qualifications: M.Sc. (Chemistry, Analytical Chemistry, Biotechnology) / B.Pharm / M.Pharm 2 to 4 years of hands-on experience in QC Analytical in a cGMP-compliant pharmaceutical or biopharma lab Key Skills: Handling of oncology molecules is plus Proficient in handling HPLC, GC, and other analytical instruments Familiarity with pharmacopeial testing (USP, EP, IP) Good understanding of cGMP, GLP , and data integrity practices Strong documentation and observation skills Working knowledge of LIMS or electronic data systems is an advantage Job Type: Full-time Pay: ₹20,000.00 - ₹50,000.00 per month Benefits: Provident Fund Experience: Laboratory: 10 years (Required) Clinical laboratory: 10 years (Required) Laboratory procedures: 10 years (Required) Laboratory techniques: 10 years (Required) Work Location: In person

Job Summary: We are seeking a dedicated and detail-oriented QC Microbiologist with 2 to 4 years of experience in pharmaceutical/biotech microbiology labs. The ideal candidate will be responsible for performing microbiological testing to ensure compliance with GMP standards and regulatory requirements. Key Responsibilities: Perform routine microbiological testing including: Sterility testing Water and air sampling Environmental monitoring (EM) Bioburden and endotoxin testing Identification of microorganisms Microbial limit tests Maintain microbiological data and logbooks. Participate in media fill validations and aseptic process simulations. Prepare and review SOPs, protocols, and reports related to microbiology activities. Ensure all testing and documentation complies with GMP, USP, EP, and regulatory guidelines. Support microbiological investigations (OOS, deviations, CAPAs). Operate and maintain laboratory instruments such as autoclaves, incubators, particle counters, etc. Coordinate with production, QA, and validation teams for sample planning and testing timelines. Assist in audits and regulatory inspections as needed. Qualifications: · B.Sc. / M.Sc. in Microbiology, Biotechnology, or related life science discipline. · 2 to 7 years of hands-on experience in QC Microbiology within a regulated pharmaceutical or biotech environment. · Knowledge of cGMP, GLP, and regulatory guidelines (FDA, EMA, WHO). · Familiarity with microbiological techniques and cleanroom classifications. · Good documentation practices and understanding of data integrity principles. · Proficiency in MS Office and LIMS (Laboratory Information Management System) is a plus. Job Type: Full-time Pay: ₹10,000.00 - ₹30,000.00 per month Benefits: Provident Fund Ability to commute/relocate: Pondicherry, Puducherry: Reliably commute or planning to relocate before starting work (Required) Work Location: In person

Job Summary: We are seeking a qualified and proactive Safety Officer with a mechanical engineering background to ensure compliance with occupational health and safety (OHS) guidelines. The Safety Officer will be responsible for implementing safety policies, conducting risk assessments, and promoting a culture of safety in all mechanical operations and projects. Key Responsibilities: Enforce safety protocols and regulations across mechanical engineering activities. Conduct regular site inspections, hazard identification, and risk assessments. Investigate incidents/accidents, determine root causes, and recommend corrective actions. Assist in the development and implementation of safety management systems (SMS). Ensure proper usage and maintenance of Personal Protective Equipment (PPE). Organize and conduct safety training and toolbox talks for employees and contractors. Maintain records of safety inspections, incidents, and training. Ensure compliance with local, state, and national safety regulations. Collaborate with engineers and project managers to integrate safety into project planning and execution. Monitor mechanical operations (e.g., heavy machinery, fabrication processes) for safety compliance. Qualifications & Skills: Bachelor’s Degree or Diploma in Mechanical Engineering or related field. Certification in occupational health and safety (e.g., NEBOSH, OSHA, IOSH). 2–5 years of experience in a safety role, preferably in a mechanical or industrial environment. Strong knowledge of mechanical systems and associated risks. Familiarity with safety laws, regulations, and best practices. Excellent communication, observation, and problem-solving skills. Ability to work independently and as part of a team. Preferred: Experience in sectors like construction, oil & gas, manufacturing, or power plants. First Aid and Fire Safety certifications. Working knowledge of safety software or digital reporting tools. Job Type: Full-time Pay: ₹15,000.00 - ₹20,000.00 per month Benefits: Provident Fund Ability to commute/relocate: Pondicheri, Puducherry: Reliably commute or planning to relocate before starting work (Required) Education: Bachelor's (Required) License/Certification: OSHA (Required) NEBOSH (Required) IOSH (Required) Work Location: In person