Job Description

Your mission

As QC Specialist, you will be responsible for ensuring continued Good Manufacturing Practice (GMP) – compliant activities within QC to support the manufacture and release of plasmids and gene therapy products.

This role will be a part of aiding a GMP facility for the production of gene therapy products. As such, it will involve participating in and providing subject matter expertise in equipment qualification, method transfer and routine in-process and release testing within the QC labs, in addition to other QC-supporting activities.

Job Description

Major Activities

• Support Technical transfer of the drug substance dilution to QC Shannon.
• Bridging study for QC dilutions to compare dilution regime in QC to previous TFF to DS dilution.
• Execution of dilution studies with including equipment installations and qualification.
• Support QC stability studies are planned, effectively tracked, monitored and achieved in accordance with agreed timelines.
• Support QC stability studies are implemented in accordance with international standards and relevant regulations.
• Support for issues, CAPAs, Change Control, Action items and risk assessment within QC.
• Ensure timely escalation and resolution of QC issues to site leadership team.
• Lead major investigations into issues impacting QC analysis.
• Keeping up to date with latest developments in methods and regulations for ATMP analytics.
• Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
• Contribute to cross departmental activities and providing expert advice and technical input where needed.
• Assure the data integrity of all activities is maintained throughout the data lifecycle.
• Proven ability in leading investigations of incidents/ deviations/ OOS/ OOTs etc.
• Proven ability in proposing change controls, CAPAs and their implementation.
• Serve as a technical expert to develop, qualify, validate and troubleshoot HPLC, Capillary Electrophoresis, PCR and Cell culture assays.
• Act as Technical SME for QC-analytics team during regulatory inspections and audits.
• Prepare, review, and approval of protocols/ reports for QC related activities such as method validation, transfer, critical reagent qualifications, reference standard establishment/ qualifications etc.
• Support QC manager in planning, execution, and delivery of QC project deliverables in time.
• Responsible for ensuring that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance’s, and is undertaken in accordance with applicable procedures (e.g., SOP’s, Protocols, etc).
• Ensure area compliance with Quality, Safety and Environmental systems and procedures.
• Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved.
• Support new product introduction and other strategic related activities in QC analytics.

Additional Activities

• Assist in the introduction of new analytical methodology for testing gene therapy products.
• Key Performance Indicators
• All QEs are on time.
• Time delivery on project in line with business needs and timelines.

Key Job Competencies

• Analytical - Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to compliment data.
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.
• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others and accepts feedback from others.
• Cost Consciousness - works within approved budget; develops and implements cost saving measures.
• Motivation - achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently.
• Professionalism - approaches others in a tactful manner; 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; responds 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 Responsibilities

• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
• Responsible to assure all activities within remit are in compliance with GMP.

Job Background

• Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics,).
• Substantial experience, minimum 8 years, working in the Pharmaceutical/Biotech industry.
• Demonstrate knowledge of current regulations and industry trends for Gene therapy/ Biologics products batch release/ stability studies/ validation testing including cGMP, ICH, EMA and FDA guidelines.
• Demonstratable audit and client facing experience.
• Demonstrate a strong understanding of latest developments in methods and requirements of guidelines such as USP, EP etc.
• Good collaboration, communication and conflict resolution skills.
• Has a strong understanding and demonstrated experience in GMP, Good Documentation Practices in QC.
• Good technical writing skills.