Anurag Bhardwaj

• Monitored quality standards and compliance levels at the plant to consistently meet regulatory requirements.
• Prepared sites effectively for inspections and ensured timely closure of audit findings.
• Ensured effective operation and maintenance of Quality Management System (QMS).
• Implemented robust investigation process for efficient identification and application of necessary CAPAs promptly.
• Implemented prompt communication channels to elevate quality concerns to management.
• Executed site-level procedures for handling returned and recalled products efficiently.
• Facilitated site compliance review for the Quality Governance group.
• Ensured consistent adherence to data compliance standards throughout the site.
• Maintained control over product processing by adhering to established PQR trends, ensuring consistency in processes.
• Managed facility maintenance in alignment with regulatory standards.
• Conducted regular audits to align policy documents with current EU GMP, WHO, Ukraine, Russia, and ISO guidelines.
• Review and release or reject product batches for distribution for different markets e.g. as per Market Authorization Application for EU products.
• Facilitated discussions to assess process performance and identify improvement opportunities.
• Maintained rigorous systems and processes to ensure product quality and streamlined processes, enhancing overall efficiency.
• Management Representative Responsibilities to ensure:

· The quality management system conforms to the requirement of ISO standards.

· Processes needed for the quality management system are established, implemented and maintained.

· The processes are delivering their intended outputs.

· Reporting on the performance of the quality management system and on opportunities for improvement, in particular to top management.

· The promotion of customer focus throughout the organization.

· Integrity of the quality management system is maintained when changes to the quality management system are implemented.

Management of all identified non routine improvement projects. To ensure that all identified actions are initiated and implemented in time.

• As a specialist in Access Services was responsible for diverse activities like process Improvisation, improvise work quality and to enhance productivity through innovative ideas and implementation of novel techniques.
• Performed gap analysis for existing procedures and practices to emphasize real time concerns and to bring down solutions.
• Involved in risk analysis for future projects.
• Supported in updation of all lab equipment and facility qualification protocols in order to align them with regulatory requirements and industrial standards.
• Helped to prepare validation/qualification protocols for new processes / equipments.
• Prepared VMP for Access lab and ensured qualification activities for facility and equipments like HVAC, Autoclave, LAFs, Biosafety Cabinets etc.
• Ensured process and procedure are audit ready.
• Performed filter Validation Activities: Team leader for Physical testing (Product based Bubble point studies, Diffusion/Water Intrusion studies and Compatibility Studies).
• Helped to plan, allocate and execute Filter Validation and Lab Activities on weekly, monthly and Quarterly basis in accordance with customer committed time lines and simultaneously considering all process variables, analyst availability, inventory status and practical feasibility of the process.
• Involved in handling all projects swapping and deviations from plan and to reallocate to meet customer committed timelines.
• Technical review of filter validation documents.
• World wide consistency: Member of world wide team from India. Responsible for alignment of Physical testing Policies, Customer Protocols and practices world wide.
• Quality concepts and implementations: To establish and implement in processes 'ISO Quality System' including: Formats and procedures for handling of Change control, Deviations, Incidents, OOS and CAPAs.
• Ensured Quality Documentation System.
• Supported Projects for Continual Improvement.
• Customer Support: Technical discussion with customers and trouble shooting for their shop floor issues.
• Trainings: To qualify and re qualify the analysts for execution of filter validation activities.
• Trained lab group for daily lab monitoring and aseptic area handling.
• Imparted training to customers on various aspects of Physical testing part of Filter Validation.

• Company Overview: Formerly known as Dabur Pharma Ltd
• Handling of overall plant equipments/facility validation activities, planning, scheduling and coordination with other related departments for the validation activities as per the Validation Master Plan.
• To face various regulatory audits and inspections from validation side.
• Preparation of the validation documents as per current guidelines/GMP such as: Validation SOP’s.
• Validation Master Plan.
• Preparation and review of the Validation Protocols and Reports (IQ, OQ and PQ).
• To execute, monitor and documentation of Qualification activities for various critical equipments including Lyophilizer, Vial Processing line, HVAC System, Autoclave, Steam Sterilizer, Terminal Sterilizer, Dry Heat Sterilizer, Depyrogenating Tunnel, cRABs, External Decontaminating Machine, Isolators, Sterilization In Place System, Cleaning In Place System, LAF, Garment Cubicle, Stability (Humidity and temperature controlled) Chambers, Staging rooms, Cold Rooms and Incubators etc.
• Formerly known as Dabur Pharma Ltd

• To execute, monitor and documentation of Qualification activities (IQ, OQ and PQ) for various critical equipments of water system area including PW/WFI/PS Generation and Distribution systems and production area including Lyophilizer, Vial Processing line, Autoclave, D.H.S etc.
• Review of FAT documents and to attend SAT for equipment approval.
• Preparation & standardization of SOPs, validation protocols and to carry out validation activities for various processes like water system validation, Lyophilization, and Vial processing etc.
• Active member of team involved in conceptualization and establishment of water system as per regulatory requirements by Detailed studies of source water nature (physical/chemical/biological) and its seasonable variations.
• Planning and freezing of stepwise treatments of raw water.
• Detailed review of offers and D.Qs and preparation of URS, Technical comparisons and recommendations.
• Extensive documentation to ensure maximum traceability of process and sterility at each step to minimize risk.
• Comprehensive troubleshooting to maintain GMP standards.
• Implementation of WHO, GMP requirements in premises and process.

• Company Overview: ICMR research project
• ICMR research project