Executive - Midas Care pharmaceutical Pvt. Ltd.
(2025-05)
- Manage the activities of regulatory affairs within the field of responsibility the implementation of appropriate effective regulatory strategies knowledge of ICH guidelines, CTD dossiers.
- Assist in preparing and compiling necessary documents for regulatory submissions.
- Coordinate with plant (Manufacturing Unit) to gather necessary information and documents required for registration processes.
- Follow-up with plant for register sample, working standard & impurity requirement for lab analysis.
- To prepare monthly regulatory status report and status of new registration/re-registration/post approval changes.
- Monitor overall ongoing routine task of Art Work and represent artwork in team meeting and resolve issue related to art work.
- Review of artwork and pack insert as per rules laid by respective regulatory authority.
- Work with Quality assurance department for closure of artwork related changes and ensure its timely closure and avoid its over due.
- Process improvement in artwork development process and liaise with line manager to discuss and implement these improvements.
- Maintain accurate and up-to-date regulatory documentation.
- Stay updated on changes in regulatory requirements and communication these changes to relevant stakeholders within the company.
- Provide regulatory input for product development, including reviewing and approving labelling, packaging and promotional materials.
- Legalization from Embassy, attestation from chambers of documents for registration purpose as per countries requirement.
- Sending packing instruction to factory for export order and handling queries related to it.
- Gather and analyze new product development requirements from clients, assessing product feasibility in collaboration with Regulatory Affairs and R&D teams.
- Coordinate cross-functionally with R&D, Regulatory Affairs, and Supply Chain Management (SCM) teams to evaluate Cost of Goods (COGs) for new product development projects.
- Lead end-to-end coordination of new product development activities, ensuring seamless collaboration across departments from concept to client delivery.
- Facilitate product development processes, including regulatory pathway assessment, formulation development, manufacturing process design, packaging material (packmat) development, and analytical/testing method development.
- Monitor project timelines and drive communication among stakeholders to ensure successful and timely product commercialization.
- Arranging tender documents and identification of products for tender.
- Collaborate with international partners, conduct factory inspections and ensure compliance with regulatory requirements.
- Develop and Execute strategic plans to achieve business objectives and expand the customer base.
- Build and maintain strong relationships with clients and identify new business opportunities.
- Conduct market research and analyze industry trends to stay ahead of the competition.
- Collaborate with cross-functional teams to develop and implement effective sales strategies.
- Identify, purse and close new business deals and contracts.
- Prepare and present sales reports, forecasts and analyses to management, highlighting key performance metrics and areas for improvement.
- Meet monthly Quarterly and annual sales targets.
- Build and maintain strong relationships with key clients and decision-makers.
- Understand client's needs, challenges and objectives.
QC Officer (Microbiologist) - BDH Industries Ltd.
(2023-09 - 2025-04)
- Sterility Testing of General Injection, Anti-Cancer Injection, sterile ointments, Raw Material, Packing Material.
- Antibiotic Assay for Injection, Ointments, Raw Materials, Tablets, Eye Drops.
- Media fill activity for Anticancer Injection, Ointments, General Injection Area.
- Preservative efficacy Test.
- Performing and monitoring Microbial Limit Test, Bioburden test for raw and Finish products.
- Metal particles test in ophthalmic ointments.
- Viable count test for nitrogen gas.
- Preparation of SOP (Micro Dept.), STP & Protocol for test of Finish Product (Microbial analysis).
- Performing & Preparation of Validation Protocol & Report for Microbial Method Validation of Finish Product (Spike test method), Disinfectant Efficacy Study (Swab method) & Other Micro Related Testing.
- Training of fresher and conducting standardized biological & microbiological Analysis.
- Carrying out Environmental Monitoring of Sterile and Non sterile Manufacturing Area, Microbiology lab & Warehouse area by exposed plate method & Air sampling method.
- Carrying out tests like total viable/fungal count and pathogens of Raw material & finished products.
- Microbial Limit test of Purified water, Distilled Water, Steam water, Water for Injection and Highly purified water.
- Bacterial Endotoxin test (BET) of General Injection, Anti-Cancer Injection, Water for Injection.
- Procurement, maintenance and performing viability test & identification for pure mother culture.
- Growth Promotion test (GPT).
- Drain Analysis, BOD and COD of Effluent water.
- Routine calibration of all instruments used in Microbiology Dept.
- Preparation of Water Trend, Environmental monitoring trend & summary report of water validation.
- Online documentation with respect to GLP/GMP.
QC Officer (Microbiologist) & QA Officer - Rank Organics Chemical Pvt. Ltd.
(2016-03 - 2021-03)
- Investigate, Audit, conduct root cause analysis, handle processing of determination, track and trend finding
- Conducted quality audit of suppliers and present results for investigations to senior staff and prepared return reports concerning investigation activities.
- Assist development and maintenance of documents and tools to complement regulatory and GMP system with international standards.
- Considerable knowledge of quality assurance auditing techniques.
- Strong knowledge of Laboratory Quality System.
- Assist with document control development related to quality systems.
- Identify defects and improve departmental performance by supporting quality, operational efficiency and production goals.
- Working within quality leadership, establish a highly effective internal audit and corrective and preventive action (CAPA) program.
- Assist in developing and providing basic and advance GLP, GMP training to Quality and operation personnel.
- Review protocols and batch manufacturing records and quality reports to assure accuracy, completeness and compliance with regulatory standards and company policies and procedures.
- Assists in Scheduling and tracking QA audits, inspections and procedures as requested.
- Writes, Reviews or Revise QA standard Operating Procedures (SOPs)/Work Instruction (Wis).
- Interaction with clients in matters of Quality Analysis.
- Supports the service delivery, internal and external complaint resolution, sales.
- Preparation of SOP (Micro Dept.), STP & Protocol for test of Finish Product (Microbial analysis).
- Performing & Preparation of Validation Protocol & Report for Microbial Method Validation of Finish Product (Spike test method), Disinfectant Efficacy Study (Swab method) & Other Micro Related Testing.
- Training of fresher and conducting standardized biological & microbiological Analysis.
- Carrying out Environmental Monitoring of Manufacturing Area, Microbiology lab & Warehouse area by exposed plate method & Air sampling method.
- Carrying out tests like total viable/fungal count and pathogens of Raw material & finished products.
- Water analysis.
- Bacterial Endotoxin test (BET).
- Procurement, maintenance and performing viability test & identification for pure mother culture.
- Growth Promotion test (GPT).
- Routine calibration of all instruments used in Microbiology Dept.
- Preparation of Water Trend, Environmental monitoring trend & summary report of water validation.
- Online documentation with respect to GLP/GMP.
- Internal & Vendor Audit.
Associate Officer – QC (Microbiologist) - Calyx Chemicals & Pharmaceuticals Ltd
(2014-10 - 2015-03)
- Performing Microbial limit test of finish & raw materials.
- Performing Antibiotic assay.
- Water analysis.
- Sub – culturing & Maintenance of pure mother culture.
- Environmental monitoring with exposed plate method and air sampling method.
- Online documentation with respect to GLP/GMP.
- Preparation of Environmental monitoring & Water Trend.
Validation Coordinator - Autocal Solutions Pvt Ltd
(2012-09 - 2014-09)
- Arranging day to day Schedules for validation at different companies.
- Making Protocols or modifying existing validations protocol (Autoclave, Incubator, Oven, Muffle furnace, Stability Chambers) as per customer requirements.
- Monitoring Record of assets required for validation.
- Checking of Validation certificates made for customer.
- Had attainted & knows the validation of Equipment's like Autoclave, Incubators Area mapping Etc.
