Malgorzata Oderinde
Harlow,Essex
Summary
Highly energetic, self-motivated, and detail-oriented professional with extensive expertise in pharmaceutical manufacturing and quality assurance. Demonstrates adaptable leadership, unwavering integrity, and a strong customer orientation while excelling under pressure to meet tight deadlines. Recognized for exceptional problem-solving skills, crisis handling capabilities, and superb communication. Possesses advanced knowledge in quality control, risk management, and compliance, coupled with proven abilities in conflict resolution, staff recruitment, workforce training, and report writing. Committed to delivering high-quality results and fostering a collaborative work environment that drives continuous improvement and excellence.
Overview
21
21
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work History
Quality Assurance Shift Manager
Lloyds Clinical
Harlow, Essex
08.2018 - Current
- Trained staff on product knowledge, resulted in better customer interactions..
- Ensured health and safety measures in line with company regulations.
- Resolved customer complaints promptly to maintain high service standards.
- Recruited new hires to strengthen the existing workforce..
- Coordinated with team members for seamless shift transitions.
- Conducted appraisals and managed disciplinary actions, ensuring team adherence to targets and timelines.
- Maintained and updated QMS metrics spreadsheets, compiling non-conformance data and co-authoring monthly Quality Measurements Reports for the Executive Leadership Team and MHRA.
- Investigated product recalls, prepared data for submission to MHRA, and reviewed patient complaints for GMP incidents.
- Managed customer complaints, deviations, and CAPA implementation to ensure timely resolution.
- Oversaw document control, supplier approvals, risk assessments, and change controls within the quality system.
- Conducted internal audits and facilitated MHRA/ISO 9001/GPhC audit preparations and follow-ups.
- Strengthened interdepartmental relationships to streamline site operations and compliance.
Quality Assurance Officer
Lloyds Clinical
Harlow, Essex
04.2010 - 08.2018
- Released aseptically manufactured medical products under MHRA “specials” license, ensuring compliance with SOPs, WIs, and GMP/GDP standards.
- Reviewed and approved batch production records, prioritizing workloads to meet delivery deadlines.
- Enhanced departmental processes, improving efficiency and minimizing workflow bottlenecks.
- Mentored new staff, ensuring regulatory standards (MHRA/ISO 9001) were met and maintained.
- Investigated environmental out-of-limit results and implemented preventive measures.
- Created and maintained internal work instructions and conducted internal ISO 9001 audits.
- Addressed defective products and patient complaints through thorough investigation and supplier engagement.
- Resolved complaints promptly to maintain client trust and satisfaction.
- Led cross-functional teams, promoted culture of continuous improvement.
- Ensured product quality by implementing rigorous inspection procedures.
- Ensured regulatory compliance, minimised exposure to penalties or sanctions.
Senior Laboratory Technician/Team Leader
Trek Diagnostic System Limited
East Grinstead, West Sussex
09.2008 - 03.2010
- Managed laboratory operations, trained new staff, and ensured compliance with GLP, FDA, ISO 9001/2008, and ISO 13485:2003 standards.
- Conducted R&D, validation, and resistance/susceptibility microbiological testing using automated and manual systems.
- Oversaw culture collection management, handling Class 2 microorganisms.
- Investigated and resolved customer complaints and performed internal audits.
- Assisted in designing experiments, enhancing overall research output.
- Supervised a team of junior technicians to enhance productivity.
- Instituted best practices for storage and handling of hazardous substances .
- Contributed valuable insights during team meetings; helped solving complex problems effectively .
Various Customer-Facing Roles
Verious employees
Crawley, West Sussex
09.2004 - 08.2008
- Carried out day-to-day duties accurately and efficiently.
- Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
- Successfully delivered on tasks within tight deadlines.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Offered friendly, efficient customer service and handled challenging situations with ease.
Education
Master of Science - Biotechnology
Polytechnic of Lodz, Poland
Lodz, Poland 01.2003 - 06.2004
BSc - Environmental Protection
Polytechnic of Lodz, Poland
Lodz, Poland 09.1999 - 01.2003
Skills
- Adaptable leadership maintaining integrity and ethics
- Customer orientation
- Problem-solving abilities
- Ability to work to deadlines, under pressure maintaining attention to detail
- Communication skills
- Quality Control
- Conflict Resolution
- Quality Assurance
- Risk Management
- Staff recruitment
- Report-writing
- Decision making
- Risk Assessment
Languages
Polish
Fluent
Affiliations
- Cooking and exploring new recipes. DIY projects and home decorating. Gardening and outdoor activities.
Certification
- Step Into Management Course (January 2022)
- Internal Auditor Course (2015, 2020)
- Introduction to Q-Pulse (2020)
- NPA Dispensing Assistant Course (2018)
- Trained Fire Marshal (Renewed 2020)
Accomplishments
- Successfully implemented departmental improvements that streamlined workflows and increased efficiency.
- Played a pivotal role in audit preparations, receiving commendations for thorough documentation and resolution of points.
- Mentored and developed high-performing QA teams, contributing to overall company success.
Timeline
Quality Assurance Shift Manager
Lloyds Clinical
08.2018 - Current
Quality Assurance Officer
Lloyds Clinical
04.2010 - 08.2018
Senior Laboratory Technician/Team Leader
Trek Diagnostic System Limited
09.2008 - 03.2010
Various Customer-Facing Roles
Verious employees
09.2004 - 08.2008
Master of Science - Biotechnology
Polytechnic of Lodz, Poland
01.2003 - 06.2004
BSc - Environmental Protection
Polytechnic of Lodz, Poland
09.1999 - 01.2003
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