Veera Price

Batch review and release of medicinal products in accordance with EU GMP Annex 16, ensuring full compliance with MA, GMP, and internal PQS requirements.

Oversight of deviations, CAPAs, change controls, and OOS/OOT investigations, ensuring scientifically sound root‑cause analysis and timely closure.

Assessment and approval of supplier and contract manufacturer qualifications, including audits, technical agreements, and ongoing performance monitoring.

Evaluation and approval of validation and qualification activities (process, cleaning, equipment, analytical methods).

Decision‑making authority on batch disposition, including risk‑based evaluation of quality issues and regulatory impact.

Participation in regulatory inspections (local and EU authorities) and preparation of responses to inspection findings.

Review and approval of quality‑critical documentation, including SOPs, master batch records, and technical reports.

Ensured compliance with controlled drug regulations, enhancing safety and accountability in operations.

Implemented internal audits for controlled substances, improving accuracy and regulatory adherence.

Led training sessions for staff on handling controlled drugs, promoting safe practices and standards.

Developed and maintained accurate records for controlled substances, ensuring transparency and traceability.

Review and QA approval of quantitative analysis results of the active substances as a part of pre-release checks and batch manufacturing records before the final QP release

Review and QA approval of Qualitative analysis results of intermediate and finished products before final QP release

Review Batch manufacturing records to ensure the quality of the prepared products

Review of the physical and environmental monitoring results of the cleanroom manufacturing areas

Overseeing RCA investigation and approval of CAPA actions

Approval of process validations

Maintenance of the Pharmaceutical Quality system

Leading Monthly Quality Reviews

Performed various administrative tasks to support team operations.

Delivered proactive oversight in setting up new pharmacy clinical trials within NHS Trust.

Ensured compliance with GMP and regulatory standards while promoting quality in the department.

Headed internal audits and implemented action plans aligned with set parameters.

Performing the final release of aseptically prepared products as a pharmacist

Pharmaceutical production under UK Medicines Act 1968 Section 10 Exemption

Coordinating all departmental clinical trial activity and evaluating the feasibility of producing new IMPs.

Liaising with sponsors regarding product development and supply, hosting audits

Formulation of aseptic products

Batch pre-release of aseptic and non-aseptic IMP and MS products

Pre-release and performing physical checks on the prepared products

Promotion of a high level of quality within the department and ensuring compliance with current GMP and regulatory standards.

Quality management within the department, including identifying and implementing appropriate corrective and preventative actions and change controls.

Oversight of the internal audit program

Executed in-process and pre-release checks of aseptic and non-sterile batches under MS and MIA(IMP) licenses, ensuring compliance and quality standards.

In-process and pre-release checking of aseptic and non-sterile batches manufactured under MS and MIA(IMP) licenses

Reviewed environmental monitoring results and maintenance records daily to uphold regulatory compliance and operational integrity.

Supervised staff, investigated deviations, and conducted internal GMP audits to maintain high-quality assurance and adherence to protocols.