What are your responsibilities?
- You will support technical projects under minimal supervision and will report to Validation Manager of Process Development.
- You will demonstrate hands on commissioning/qualification skills, including but not limited to the following: develop, implement and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures.
- You will drive the development of system commissioning qualification and validation documentation.
- Develop and Update several Validation documents.
- E.g. System Level Criticality Assessments,Commissioning, Qualification and Validation plans,Risk assessments,Protocols and reports,Requirement traceability matrices,Commissioning, Qualification and Validation summary reports
- Lead Commissioning activities, Qualification activities and Validation activities
- Deliver guidance to the project group, so the implement technical solution follows the validation plan in order to achieve meeting internal customer requirements, and accordance with SOPS
- Any other tasks/projects assigned as per supervisor request.
Who are we looking for?
- Experienced with Secondary Packaging Systems, including experience with Print and Inspection systems (e.g. Systech, Cognex)
- At least 5 years’ experience in executing Commissioning, Qualification and Validation within manufacturing organizations in the pharmaceutical industries.
- Experienced in Computerized Systems Validation
- Basic knowledge of Paperless validation systems (HP ALM/ KNEAT)
- Hands on commissioning and qualification experience within Secondary Packaging Operations.
- Good understanding of the role of a single document within the bigger picture.
- Internal and /or external reporting relationships.
- Ability to work independently and remotely with minimum direct supervision
- Good English Technical Writing Skills
- Customer relationship management skills
- Critical thinking skills
- Able to set clear priorities and escalate to ensure timely delivery of the project phases including design, development, implementation, testing, construction, commissioning, and validation.
- Experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling.
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.