Tini Mathai
Nuneaton,Warwickshire
Summary
Detail-oriented QA Officer with 1.5 years of experience in the pharmaceutical industry, ensuring compliance with GMP and regulatory standards. Experienced in batch record review, deviation and CAPA management, document control, and supporting regulatory inspections. Strong understanding of Quality Management Systems (QMS) and data integrity principles. Proactive team player with excellent attention to detail and a commitment to maintaining high product quality and patient safety.
Overview
5
5
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work history
Quality Assurance Officer
Xeal Pharma
Birmingham, West Midlands
2024.10 - Current
- Managed and maintained the Quality Management System (QMS) in compliance with GMP and MHRA requirements, ensuring ongoing regulatory readiness.
- Reviewed and approved Batch Manufacturing Records (BMRs), deviations, and change controls, ensuring product quality, traceability, and accurate documentation prior to release.
- Led deviation investigations and implemented effective CAPAs using root cause analysis tools to prevent recurrence and improve process robustness.
- Oversaw supplier qualification, raw material approval, and certificate of analysis (CoA) verification to ensure compliance with specifications.
- Investigated customer complaints and supported recall procedures, maintaining a strong focus on patient safety and regulatory compliance.
Laboratory technician
Xeal Pharma
Birmingham, West Midlands
2024.06 - 2024.10
- Manufactured unlicensed “specials” medicines in accordance with GMP and approved batch manufacturing records, ensuring accuracy, traceability, and patient-specific requirements.
- Executed in-process quality checks, verifying product specifications before QA review.
- Upheld cleanroom and production area standards, following gowning procedures and contamination control protocols.
- Accurately completed batch documentation and production logs in line with data integrity.
Junior Clinical Pharmacist
Medanta Hospital
Gurgaon, India
2021.03 - 2022.04
- Reviewed and optimized medication therapy plans in collaboration with physicians to ensure safe, effective, and evidence-based treatment outcomes.
- Conducted medication reconciliation and identified drug-related problems (DRPs), including interactions, contraindications, and dosing errors.
- Monitored patient progress through clinical rounds, reviewing laboratory results and adjusting therapy recommendations accordingly.
- Provided patient counseling on medication use, adherence, side effects, and lifestyle modifications to improve therapeutic outcomes.
Education
Masters of Pharmacology and Drug Discovery -
Coventry University
Coventry 2022.05 - 2023.06
Doctor of Pharmacy -
Rajiv Gamdhi Uiversity of Health Sciences
2014.08 - 2020.08
Skills
- Quality Management System management
- Deviation & CAPA investigation
- Change control & risk assessment
- Regulatory inspection readiness
- Strong attention to detail and accuracy
- Root cause analysis and problem-solving
- Effective cross-functional communication
- Time management and ability to work under pressure
Additional Experience
Health Care Assistant
- Delivered high-quality, dedicated care to clients with disability, consistently achieving individual care plan objectives.
- Ensured safe, secure living conditions for service users, reducing risk and enhancing quality of life.
- ·Used outstanding communication and interpersonal skills to build positive relationships with clients for exceptional satisfaction ratings.
Certification
- CMI Level 7 Certificate in Strategic Management and Leadership Practice.
- Medical Writing from Euston College, London
Timeline
Quality Assurance Officer
Xeal Pharma
2024.10 - Current
Laboratory technician
Xeal Pharma
2024.06 - 2024.10
Masters of Pharmacology and Drug Discovery -
Coventry University
2022.05 - 2023.06
Junior Clinical Pharmacist
Medanta Hospital
2021.03 - 2022.04
Doctor of Pharmacy -
Rajiv Gamdhi Uiversity of Health Sciences
2014.08 - 2020.08