Validation Officer

Reporting directly to the Production Manager in liaison with the QA Admin, the main role of the validation officer is to prepare for, coordinate and execute all site validation activities.

Responsibilities

• To coordinate and support the validation of manufacturing processes and cleaning methods as per EU cGMP, including issuing and execution of required documentation


• To support the validation and / or qualification of computer systems and facilities, utilities and equipment, including reviewing of protocols and reports as applicable


• To support the introduction of new technology at the manufacturing site as part of technology transfer projects


• To execute and report validation protocols in accordance with appropriate regulations for quality, health and safety


• To maintain the Validation Master Plan updated with the requirements of EU cGMP as applicable to the manufacturing site, including maintaining of all VMP documentation registers


• To coordinate and support ongoing process verification through relevant process and product improvement initiatives


• To support the creation of production-related documentation based on scientific integrity, and quality and regulatory requirements as applicable


• To participate in the Quality Risk Management activities of the company


• To participate in Change Control assessments and project meetings to ensure that quality and regulatory compliance are not compromised


• To ensure assigned validation exercises are conducted in a timely manner and in compliance with cGMP and project milestones. This includes validation of purified water loop, cleaning validation and process validation


• To liaise effectively with other departments


• To participate in regulatory and internal audits as necessary


• To support the day-to-day activities associated with maintaining QMS compliance, especially in the area of validation


• To undertake any quality-related events


• Any tasks assigned by the QA Admin or Production Manager


• To prepare and review departmental SOPs

Requirements

• Strong communication skills


• Self-Motivated and highly organized


• At least 2–3 years experience in a similar position would be ideal, although full training will be provided


• Ability to work independently as well as within a team

Level and Type of Education

• A degree in a life science subject or a Pharmacy degree

Required Knowledge:

• Knowledge of Microsoft Office


• Knowledge of GMP, Eudralex Chapter 4

MGC Pharma - KMP-79115