Sambavi Sackthish
St Neots
Summary
Accomplished professional specializing in strategic quality management and regulatory compliance, including MHRA and EU GMP standards. Proficient in quality governance, risk management, validation, and equipment qualification (IQ/OQ/PQ). Expertise in inspection readiness, lean six sigma methodologies, and continuous improvement initiatives. Demonstrated leadership in training and mentorship, driving organizational success through effective strategic planning.
Overview
11
11
years of professional experience
5
5
years of post-secondary education
Work history
Quality Consultant
SKS Pharma Consulting Ltd
06.2025 - 02.2026
- Provide senior quality leadership and regulatory expertise to pharmaceutical and radiopharmaceutical organisations operating within GMP-regulated environments.
- Lead inspection readiness programmes and remediation strategies, ensuring sustained compliance with MHRA and EU GMP requirements.
- Stabilise and enhance Quality Management Systems (QMS), embedding effective governance structures and risk-based oversight frameworks.
- Act as a trusted advisor to executive and site leadership teams on regulatory risk, compliance strategy, and quality transformation initiatives.
- Deliver strategic oversight across deviation management, CAPA effectiveness, change control, validation lifecycle management, and quality risk management.
- Support organisations through regulatory inspections, post-inspection remediation, and quality culture development initiatives.
Head of Quality Control
Cell and Gene Therapy Catapult
11.2021 - 05.2025
- Led organisational QC governance, ensuring full regulatory compliance and alignment with evolving GMP expectations.
- Implemented and managed environmental monitoring programmes, enhancing compliance and measurable quality improvements.
- Developed and executed departmental KPIs, improving accountability and operational excellence.
- Optimised laboratory efficiency through scheduling, resource allocation, and preventive maintenance planning.
- Led Lean Six Sigma and continuous improvement initiatives delivering measurable process improvements.
- Directed oversight of non-conformances, OOS investigations, CAPAs, change control, and audit actions.
- Oversaw qualification of rooms, utilities, and laboratory equipment (IQ/OQ/PQ) supporting inspection readiness.
- Utilised Six Sigma methodologies to achieve process optimisation.
- Fostered a culture of continuous improvement by monitoring employee performance.
- Streamlined workflow processes with a focus on risk mitigation and cost reduction.
Quality Assurance Officer
King’s College London
04.2018 - 11.2021
- Played a strategic leadership role in the development, implementation, and ongoing governance of a comprehensive Quality Management System for a new GMP radiopharmaceutical facility.
- Led quality oversight during commissioning of the site, contributing directly to successful MHRA Manufacturer’s (MS) licence approval.
- Acted as QA signatory within an MHRA-licensed facility, providing regulatory oversight of GMP documentation, batch records, and product release under the “Specials” framework.
- Directed validation lifecycle activities including facility, equipment, process, analytical, and cleaning validation to ensure inspection-ready compliance.
- Led inspection readiness planning and supported regulatory inspections, including remediation activities and closure of regulatory observations.
- Chaired risk management and management review meetings, strengthening quality governance, regulatory positioning, and senior leadership visibility of compliance risks.
- Established and managed supplier qualification programmes, including supplier audits, quality agreements, and performance oversight to ensure supply chain integrity.
- Collaborated at senior cross-functional level with manufacturing and technical leadership to embed GMP standards, enhance quality culture maturity, and deliver sustainable continuous improvement across operations.
Interim Quality Control Manager
King’s College London
10.2019 - 01.2020
- Directed routine analysis of radiopharmaceuticals, approved validation documentation and SOPs, and supported LIMS implementation including IQ/OQ qualification activities.
- Developed robust quality control procedures to ensure production efficiency.
Radiochemist
King’s College London
05.2017 - 04.2018
Lead Production Radiopharmaceutical Chemist
Alliance Medical Radiopharmacy
01.2015 - 01.2017
Analytical Scientist
Reckitt Benckiser
09.2014 - 06.2015
Education
Q3P (Trainee Qualified Person) Certification -
University College London
10.2017 - 10.2018
Master of Science - MChem Medicinal Chemistry
Newcastle University
Newcastle 01.2010 - 01.2014
Skills
- Strategic Quality Management
- Regulatory Compliance (MHRA, EU GMP)
- Quality Governance Risk Management
- Validation and Equipment Qualification (IQ/OQ/PQ)
- Quality Management Systems Implementation
- Inspection Readiness and Remediation
- Lean Six Sigma and Continuous Improvement
- Supplier and Audit Management
- Non-conformance, OOS and CAPA Oversight
- Leadership, Training and Mentorship
- Strategic planning
Accomplishments
Member of Royal Society of Chemistry
References
References available upon request.
Timeline
Quality Consultant
SKS Pharma Consulting Ltd
06.2025 - 02.2026
Head of Quality Control
Cell and Gene Therapy Catapult
11.2021 - 05.2025
Interim Quality Control Manager
King’s College London
10.2019 - 01.2020
Quality Assurance Officer
King’s College London
04.2018 - 11.2021
Q3P (Trainee Qualified Person) Certification -
University College London
10.2017 - 10.2018
Radiochemist
King’s College London
05.2017 - 04.2018
Lead Production Radiopharmaceutical Chemist
Alliance Medical Radiopharmacy
01.2015 - 01.2017
Analytical Scientist
Reckitt Benckiser
09.2014 - 06.2015
Master of Science - MChem Medicinal Chemistry
Newcastle University
01.2010 - 01.2014