Reena Chaudhary

Dedicated FDA-approved professional microbiologist with extensive experience in Quality Control and Quality Assurance within pharmaceutical manufacturing environments. Proven expertise in microbiology laboratory setup, GMP documentation, and real-world evidence generation, combined with strong project management skills. Able to work independently and collaboratively within multidisciplinary teams, with excellent communication skills in cross-cultural organizations.

Demonstrates strong organizational abilities and attention to detail.

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.

M.Sc - Biotechnology - Kalinga University (2015)

P.G Diploma - Digital & Cyber Forensic - Institute of Science Mumbai University (2012)

B.Sc. - Biotechnology - Sonopant Dandekar Arts, V.S Apte Commerce and M. H. Mehata Science College (2009)

HSC - ATOMIC ENERGY JUNIOUR COLLEGE TARAPUR (BOISAR) (2006)