Sr. Validation and Process Engineer- Switzerland- Contract
We are looking forward to speaking to talented and responsible Validation Specialists to join our client, a world leading pharma that is going to offer tremendous professional development and learning opportunities, as well as opening future career doors.
You would be accountable for the laboratory instruments qualification, including Computer System Validation (CSV) in the QC laboratories and would also support the deployment of Data Integrity (DI) in the department, offering you cross funtional resposibilities that are going to expand your network globally whilst learning from the best!
In this diverse and challenging role your accountabilities will include:
- Generation, execution and review of life cycle validation documentation for commissioning of processes
- To ensure that all documentation is prepared, authorised and completed in a timely manner.
- To ensure that all tasks are carried out in an effective and efficient manner.
- To ensure that appropriate training records are maintained.
- To communicate effectively with others on site and the client associated with the project.
- To supervise work of those undertaking validation activities
- To maintain an understanding of current international regulatory, ISO, corporate and client requirements relevant to the section.
- To ensure compliance with the sections and site procedures.
- To liaise with the various departments involved in the qualification and validation work to ensure the efficient performance of the related tasks.
- To ensure that adequate training has been received and documented
- To present qualification activities to an auditor
- Comply with GMP requirements and company rules, policies and procedures.
- Deliver coordination and management to the Technology Transfer of new, PDS transfer or internal commercial products onto site leading the internal site team against
You will be an experienced Quality Operations/Validation professional with and in depth knowledge or GMP along with previous experience of using the "V" model approach to validation. You'll have a project managment back ground in either Engineering, Validation or Quality and will have worked with clients as well as internal stakeholders.
In addition to this you must be able to demonstrate:
- In-depth knowledge and understanding of cGMP.
- Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
- Demonstrable experience in Quality Operations/Validation of process validation
- Previous experience of applying "V" model approach to validation activities
- Creativity, judgement and analytical thinking.
- Ability to work with critical timelines.
- An excellent planner, who can envision short-term milestones which the company must achieve to succeed in the long-term.
- Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
- Strong project ownership ethic with a "can do" attitude.
- Ability to motivate, communicate and lead cross functional teams to deliver project timelines
- The drive and maturity to lead combined with the ability to support and interface effectively with projects and motivate cross functional teams
If you are up for the challenge, send your profile across to Alex at email@example.com so he can give you more details about the role!
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