Job Description

Your mission

The QC Validation Specialist is responsible for the validation and technology transfer of novel and established
test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU
and FDA GMP requirements.

Major Activities

• To support the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
• Generate validation test protocols, data analysis, and reports in support of the method transfer and validation activities performed ensuring compliance requirements are maintained.
• Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
• Generate method SOPs are developed and implemented to support all validated methods. Ensure these are current.
• Ensure timely communication to method transfer progress and plan adherence.
• Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
• Perform routine assessment of the analytical methods used to ensure they are being applied arid operating as expected.
• Support with maintaining the Quality Management System and controlling documents and ensuring the data integrity of all data produced.
• Ensure own KPl's, plans, targets, and objectives are effectively tracked, monitored, and achieved in accordance with timelines.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) lssues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
• When required may be assigned testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule.

Key Performance Indicators

• Implementation of test methods to meet site KP/ requirements.
• Quality control audits.
• Plan, manage and record training effectively.

Key Job Competencies

• Identifies and resolves problems in a timely manner; gathers and analyzes information skilfully; develops alternative solutions and works well in group problem-solving situations.
• Cost consciousness - works within approved budget; develops and implements cost-saving measures; contributes to profits and revenue; conserves organizational resources.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; develops realistic action plans.
• Professionalism - tactfully approaches others; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and
• thoroughness.
• Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; response well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Job Experience / Professional Background

• Degree or Master's in human health or Sciences, 2 years work experience in the pharmaceutical or other similar regulated industry (i.e. Biologics).
• Demonstrate experience in an analytical methods/validation role in the research or pharmaceutical industry.
• Preferably experienced with analytical techniques like qPCR, HPLC (RP-HPLC/SEC), ELISA, SOS/Western blot, cell-culture and DNA extraction.
• Proficiency in a body of information, mainly, ICH Q2(Rl) guidelines.
• Proficiency in IT, Microsoft Office software (Word, Excel, PowerPoint) preferred.