SHAKILA BANU

• Directed regulatory interactions with health authorities (CDSCO) and prepared comprehensive regulatory dossiers (eCTD, CTD, IND, NDA, and ANDA), ensuring timely product approvals and compliance.
• Oversaw the preparation and control of Master Batch Records (BMR/BPR) and Standard Operating Procedures (SOPs), demonstrating high-level documentation control skills relevant to environmental policy development.
• Manage environmental documentation and compliance, and maintain critical documentation, ensuring adherence to regulatory requirements and facilitating compliance.
• comprehensive records, including Material Safety Data Sheets (MSDS), to ensure compliance with corporate governance requirements
• Prepare technical documentation reports, procedures (SOPs), and comprehensive documentation critical for environmental assessments and permits.
• Coordinated the successful implementation of an ISO 14001-certified Environmental Management System, collaborating with cross-functional teams to author and refine all required documentation.
• Authored and managed all EMS documentation, including the Environmental Policy, objectives, procedures, and work instructions, ensuring seamless ISO 14001 compliance during annual audits.
• Managed all hazardous waste tracking documentation, ensuring full compliance with environmental regulations and providing comprehensive training to personnel on best practices.
• Prepared and submitted environmental reports and permit documentation to regulatory agencies, securing timely approvals and preventing any compliance violations.
• Managed robust Quality Assurance and Control processes, including batch document reviews, in-process QA checks, and regulatory standard adherence.
• To ensure that adequate and complete records relating to GDP are maintained.
• Preparation of documentation as per local cGMP and FDA requirements.
• Preparation of deviation, change control, and OOS (Out of Specification). Corrective and Preventive Action Plan (CAPA).
• Reviewed labeling and promotional materials for regulatory compliance.
• Monitored changes in regulations impacting product registration and approval.

• Oversaw Quality Assurance and Quality Control functions, including the development and implementation of quality systems. These are readily adaptable to establishing and maintaining environmental management systems.
• Managed and updated documentation related to quality systems, ensuring compliance, and data integrity. This mirrors the requirements for environmental data management and reporting. Preparation of BMR, BPR Master Copy, and Control Copy.
• Preparation of the SOP and specification.
• Issue blank BMR/BPR to production, and check completed BMR, reviewed retrievals, and document store.
• To review batch documents and confirm that the batch meets the relevant regulatory standards.
• Maintaining and updating the Batch Manufacturing Records.
• Maintaining, reviewing, and upgrading various Quality Assurance records, such as validation and calibration.

• Preparation of Certificate of Analysis as per BP, USP, IP, EP, and Party Specification.
• Review of analytical method validation protocols and reports, as per the regulatory requirements.
• Analysis of raw materials, packing materials, in-process samples, and finished products.
• DM Water Testing and Reporting.
• Review the stability study data as per ICH guidelines, and assign the re-test period.
• Preparation of reagent, indicator, volumetric solution, and standardization.
• Preparation of the finished product COA as per requirements.
• Qualification of reference/working standards.
• Sampling of raw materials and finished products as per requirements.
• Daily and monthly calibration of instruments, balance, pH meter, and KF water factor.
• Calibration of instruments, as per the master calibration schedule.
• Good knowledge of Analytical Instrument Qualification procedures.
• Handling of OOS and OOT analysis for API molecules.
• Contributing to the daily analysis (like raw material, in-process, and finished product samples), maintaining the lab notebooks and written reports, and reporting the work plan accordingly.
• Performed quantitative and qualitative analysis of chemical compounds using gas chromatography, spectrophotometry and other analytical techniques.

• Ensure all regulatory requirements of health authorities are met and approval is obtained from the FDA, FSSAI, and CDSCO.
• Preparation of BMR, BPR,SOP,STP, Master Copy, and Control Copy.
• Issue blank BMR/BPR to production, and check completed BMR, reviewed retrievals, and document store.
• To review batch documents and confirm that the batch meets the relevant regulatory standards.
• Artwork corrections and approvals are given to ensure each product's label complies with all labeling requirements.
• Performing in-process quality assurance checks for tablets, capsules, and liquid orals.
• Maintaining and updating the Batch Manufacturing Records
• Preparation of Deviation, Change Control, OOS (Out of Specification), Corrective & Preventive Action Plan (CAPA).
• Maintaining, reviewing, and upgrading various Quality Assurance records, like Validation and Calibration.
• Ensure analysis data, and maintain the logs.
• To report any out-of-specification or out-of-trend results and assist with the deviation during the investigation.
• Conducted routine testing of raw materials and finished products for quality assurance.
• Developed and validated analytical methods to ensure compliance with industry standards.
• Collaborated with production teams to resolve quality issues and improve processes.

Exposure in Vendor Management :

• Handling of vendor qualification management for new/existing vendors
• Carry out vendor audits to ensure the quality of Raw material/intermediates and to develop the new vendors
• Party Fill the Supplier and Vendor Questionnaire

Exposure in customer and regulatory support :

• Handling customer queries and complaints
• Responsible for responding to any regulatory queries on behalf of the project team, with inputs from other team members.
• Review of process development and analytical reports.
• Setting up of specifications (Key starting materials, Intermediates and API)

• Analysis of raw materials, packing materials, in-process samples, and finished products.
• Preparation of Certificate of Analysis as per BP, USP , IP , EP & Party Specification
• DM water testing and reporting.
• Preparation of Reagent, Indicator, Volumetric solution & standardization
• Preparation of finish product COA as per requirements
• Qualification of Reference/working standards
• Sampling of raw materials & finish product as per requirements
• Daily & Monthly calibration of instrument , Balance, pH Mater, KF- Water Factor