Your mission
Purpose of Job
To support the qualification activities of various equipment and systems for the Manufacturing, Quality Control (QC) and Engineering departments, within a state of the art gene therapy manufacturing facility.
Job Description
Major Activities
- To assist in writing and reviewing of Validation protocols, as well as coordinating post execution reviews and approvals.
- To assist in the execution of Validation protocols, performed by internal or external resources.
- To support system owners with system/equipment User Requirement Specification (URS) and DQ (Design Qualification) documents and using a risk-based approach to determine the appropriate validation requirements.
- 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 e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a Right First Time (RFT) state.
Key Job Competencies- 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.
- Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources.
- 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.
Job Background- Degree or equivalent, preferably with a higher qualification in a discipline related to Engineering and/or Bio-pharmaceutical Sciences.
- Excellent collaboration skills.
- Excellent verbal and written communication skills, in English.
Why us?