QA Validation Specialist

Our client, who is one of the world’s largest and most broadly based healthcare company are now looking for a Quality Validation Specialist to one of the world’s largest and most broadly based healthcare company, Initial duration is three months but can extended but the assignment can be extended.

Objectives of the Position
• QA-Review and approve validation documentation. Decommissioning, SAT, FAT, DQ, IQ, OQ and PQ documentation according to GMP / ISO13485 and J&J internal requirements.
• Lead change case related to Validation process for process and product
• Quality assurance of deviations and CAPA- Quality-assured deviation and CAPA investigations as well as quality-assured corrective and preventive action plans related to the Validation process.
• Take decisions as QA for validation steps.

Qualifications
- Min Bachelor (required) Preferable a master’s degree in Science (preferred and an advantage).
- A min of 5 years of experience in either life science industry, pharmaceutical or Medical Device.
- Good knowledge of national and European ISO (ISO13485 as prefer) and GMP regulatory requirements.
- Experience from managing deviation during Validation and review and approval of validation documentation. Min 3-5 years as QA validation/validation leader.
- You are a fluent speaker of Swedish and have proficiency in oral and written English.
- You are proficient in common computer programs (MS Office and others).

What you will need to succeed
- You are a dynamic and ambitious professional, willing to work hard and devote time, energy, and commitment to the work.
- You are analytical and have a structured and organized working style.
- You can listen and create an atmosphere of trust and mutual respect.
- You have a great command of communication skills, verbal, oral and written, and you have good presentation skills.
- You can work independently in a virtual and matrix environment, but at the same time you are a team player with the ability to work under own initiative, self-starting and proactive.
- You are strongly performance-oriented with a passion for delivering quality.
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release, and distribution processes.
- Your self-leadership skills are well developed, and you work independently.
- Proven self-starter with good initiative and enthusiasm.
- Strong work ethic, structure, and results orientation.
- Flexible and comfortable with ambiguity in a dynamic and changing environment.
- Able to prioritize in a highly matrixed environment.

We look forward reading your application.