Suni Daniel

• Conductinternal audits to ensure compliance with ISO standards, QMS requirements, and
client guidelines.
• Monitor QMS performance, track CAPA actions, and ensure timely closure of non
conformities.
• Prepare, review, and maintain audit documentation to support external and regulatory
audit readiness.
• Identify process gaps and implement improvements to enhance operational efficiency
and quality compliance.
• Deliver QA, compliance, and SOP-based training to staff to strengthen quality awareness.
• Collaborate with cross-functional teams to resolve quality issues, streamline workflows,
and improve service delivery.
• Review, update, and control SOPs and quality records to maintain documentation
accuracy and audit compliance.

• Conducted 15+ internal audits across hospital departments aligned with NABH standards.
• Reviewed and monitored 200+ service records, complaints, and compliance reports monthly.
• Prepared monthly MIS reports and quality dashboards for senior management review.
• Coordinated quality improvement activities with 10+ departments to improve operational efficiency.
• Supported timely closure of audit observations and corrective actions within targeted timelines.
• Supported risk identification, service quality improvement, and corrective action planning.
• Analysed operational data and prepared quality snapshots and MIS reports for management review.
• Maintained governance documentation and quality performance dashboards.
• Coordinated with teams to enhance turnaround times, communication quality, and service consistency.

• Supervised purity testing and hallmarking processes.
• Implemented documentation systems per BIS requirements.
• Conducted internal audits and planned corrective actions.

• Supported QA activities for oncology oral solids and injectables in GMP-regulated manufacturing.
• Managed and reviewed 80+ deviations, CAPAs, change controls, and OOS investigations.
• Executed batch release and documentation review activities through SAP and LIMS.
• Conducted 150+ in-process checks and line clearance activities ensuring GMP compliance.
• Supported multiple GMP audits and regulatory inspections with complete documentation readiness.
• Delivered SOP and GMP training sessions to 20+ production and QC personnel.
• Applied Quality Risk Management principles in GMP manufacturing for oncology oral solids and injectables.
• Conducted risk assessments linked to deviations, change controls, and OOS investigations, ensuring patient safety and
regulatory compliance.
• Performed line clearances before batch start, verifying equipment, materials, and documentation for full GMP
compliance.
• Reviewed, investigated, and closed change controls, deviations, and OOS investigations before batch release;
implemented CAPAs as needed.
• Supported GMP audits, inspections, and regulatory documentation readiness.
• Ensured data integrity and compliance during SAP and LIMS-based batch release activities.
• Conducted training sessions on SOPs and updates for production and QC teams.

• Reviewed and approved 700+ batch manufacturing and QC records for GMP compliance.
• Maintained structured quality documentation ensuring audit readiness and traceability.
• Managed closure of 80+ deviations, CAPAs, and change control records.
• Conducted routine internal audits and process improvement activities.
• Performed SAP and LIMS-based batch review and data verification activities daily.
• Contributed to continuous improvement initiatives through deviation trend analysis and corrective actions.

• Performed in-process checks and GMP monitoring for manufacturing and packaging.
• Maintained SOPs, batch records, and QA documentation per ISO & GMP guidelines.
• Coordinated internal audits, managed CAPA, and supported regulatory inspections.
• Improved quality performance through cross-functional collaboration.

Chem International Independent Inspection & Testing Company for 03 months during academics.
Roles and Responsibilities:-
•Officer Quality Assurance
•Issuance, control and retrieval of quality system related documents i.e. batch manufacturing records, batch packaging records, sops, log books and specifications etc.
•Preparation and control of QA related SOPs.
•Line clearance for the equipment’s, critical stages in manufacturing, dispensing and packaging activities
•In process checks (IPQA) activities during manufacturing and packaging activities.
•Daily monitoring of dispensing, manufacturing and packaging activities.
•Daily production area GMP round for the compliance and coordination with the other departments for the process related issues.
•Review of batch manufacturing records, batch packaging records and QC raw data.
•War room participation in regulatory, customer and internal audits.

•Senior Executive Quality Assurance
•Handling “Track Wise” Quality Assurance Management System (QAMS) software for Change control, CAPA, Market complaints ad Deviations.
•Preparation of crystal reports from QAMS, and Quality indicator reports.
•Handling SAP activities for transfer and batch release activities.
•Handling “LABWARE” software for Laboratory Information Management System (LIMS) for the role as QA release for disposition. (Batch release) and for Stability intimations.
•Handling “PharmaReady” Document Management System (DMS) software having roles as author, owner, and reader of documents such as SOPs, AVL / ASL and BMRs/BPRs.
•Preparation of APQR (Annual Product Quality Report) and PRR (Product Review Report).
•Conducting training on GMP related topics and evaluation.
•Coordinate training programs with other departments regarding GMP issues.
•Coordinate on the quality related matters with other department concerns.
•Preparation of audit compliance reports.
•Issuance, control and retrieval of quality system related documents i.e. batch manufacturing records, batch packaging records, SOPs and specifications etc.
•Daily monitoring of Dispensing, Manufacturing and Packaging activities.
•Line clearance for the equipment’s, critical stages in manufacturing, dispensing and packaging activities.
•Daily production area GMP round for the compliance and coordination with the other departments for the process related issues.
•Preparation and control of SOPs.
•Review executed batch manufacturing records, batch packaging records and QC raw data.
•Review of process validation documents.