Anu Usha

Over 8+ Years' Experience in Pharmaceutical industry - Quality Assurance and Quality Control- GMP. Review and Issuance of Batch Documentation (BMR, BPR). Good experience on caliber LIMS and QMS. Excellence in handling Out of specification (OOS), Out of trend (OOT) and laboratory Incident (LI) Investigations.

Experience in review and approval of analytical data in quality control department for GMP compliance. Good knowledge of CGMP, ALCOA, GDP, Data Integrity and 21CFR part 11.

Experience in handling of deviations, change controls, Risk assessment and CAPA.

Experience in using SDMS, Lab solutions, Caliber QMS, Empower 3 software.

Experience in Operation and troubleshooting of various analytical instruments in QC lab like HPLC, UV, Dissolution, Friabilator, Disintegration, Hardness tester, KF, TLC.

Experience in Preparation of POR, PVR, COAs, reports, protocols, manual worksheets, validated excels for process validation and stability studies. Excellence in usage of LIMS for data handling in Pharmaceutical industry.

Experience in preparation, Revision/Review of the Standard Operating Procedures (SOPs), In-process spec and other technical documents. Overall knowledge in process flow of FP (Finished Product), PV (Process validation) and Stability studies.

Quality Assurance supervisor - Bird Brothers ltd - Bedford, UK

(2025-05 - 2025-12)

• Monitor and record all quality issues with incoming egg.
• Book all incoming egg onto the data base, always ensuring full traceability and product compliance.
• Ensure all department cleaning schedules and control paperwork is fully completed and up to date.
• Carry out internal audits to schedule and report non-conformances.
• Maintain the compliance training for all team members in line with requirement.
• Assist in maintaining all relevant records and information required by Bird Bros and External Audit bodies, and play an active role in both internal and external audits.
• Monitor and investigate complaints.
• To assist in the development of an effective quality assurance system, ensuring that quality and food safety are appropriately managed to meet set objectives.
• Actively take part in pest control and monitoring procedures.
• Carry out quality, weight & legal checks on ungraded & graded eggs as required, to cover absence / holidays within the Quality team.

Quality assurance officer - Bristol Laboratories Limited - Luton, UK

(2020-12 - 2024-10)

• Filled TRF(Test request forms), Sent and received deliveries of samples from and within sites and Registered samples into LIMS accurately.
• Reviewed and recorded transported data from data loggers and checked for any deviations.
• Ensure samples are stored in the correct locations in a timely manner.
• Maintained sample rooms for storage of samples to be analysed.
• Timely reconciliation of samples to ensure storage space usage and requirements for upcoming work.
• Coordinate and monitor quality control activities to ensure compliance with GMP, GDP and regulatory standards.
• Coordinate with QC for laboratory testing schedules to ensure timely completion of QC analysis.
• Review, update and reconciliation SOPs.
• Being primary point of contact in QC team and providing information to other departments and maintain personnel training up to date.
• Assisted in regulatory and internal audits by organizing QC documentation, including SOPs, Sample logs, temperature reports and test data.
• Providing cGMP and Data integrity awareness training in Quality Control department.
• Identify opportunities for improvements within QA/QC procedures and documentation.
• Performing GEMBA walk in packaging and manufacturing area.
• Conduct audit trail review of electronic laboratory systems, as required.
• Review and approval of calibration and qualification data for QC laboratory equipment.
• Engage in intra-departmental and cross functional/ organizational relationships to drive quality system requirements.

Quality Control Analyst - Bristol Laboratories Limited - Luton, UK

(2016-06 - 2020-11)

• Testing of all laboratory samples including Finished product, stability, process validation as per specifications, using various techniques such as HPLC, GC, KF, UV-Vis, IR, and Dissolution in accordance to pharmaceutical cGMP.
• Ensuring all cGMP/GLP requirements and strictly adhere to the Sop's and are followed at all times.
• Recording and Reporting of analytical results as per Good Documentation practices.
• Identify and report any OOS/OOT/OOE results to supervisors.
• Operation Maintenance and calibration of laboratory instruments.
• Maintenance and usage of laboratory chemicals, laboratory notebooks, Instrument logbooks and registered as per lab procedures.
• Reporting non-conformance, Accident and other abnormal occurrences to immediate superiors.
• Ensuring Laboratory tidiness, health and safety at all time.
• To prepare, review and update SOP's for the QMS as applicable.
• To participate in GMP self inspections, Internal quality audits, External audits and Regulatory inspections.

QA Analyst - GlaxoSmithKline (GSK) - Worthing, UK

(2015-10 - 2016-04)

• Routine analysis of QC release, stability in-process and raw materials in defined analytical methods and SOPs.
• Preparation and maintain laboratory chemicals, mobile phase and working standards.
• Analyzing parameters like assay, water content, Dissolution, Friability, thickness and hardness.
• Participate in identification of OOS and OOT results.
• Calibration and maintain dissolution apparatus, PH mater, analytical balances and Karl fisher conductivity meter.
• Analysis of materials using chromatographic (HPLC) and spectroscopic (UV, FT-IR) techniques.
• Expertise in HPLC trouble shooting, Column regeneration, Interpretation and calculation of results by using Empower 3 to create spread sheets, graphs and compare to established methods, specifications and control limit.
• Compliance with GDP, ALCOA, LIMS.
• General housekeeping and maintenance of laboratory environment.
• To comply with H&S, MHRA requirements, to assist in risk & COSHH assessments.
• Familiar with GMP, GLP, ICH and other guidelines.

Bachelor of Pharmacy - Pharmacy - Acharya Nagarjuna University (2007 - 2011)

Master in Pharmacology - Pharmacology - Acharya Nagarjuna University (2011 - 2013)