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Validation Specialist
3 weeks ago
We are seeking a skilled Validation Specialist to support validation activities including development, implementation and maintenance. The ideal candidate will ensure qualification activities are performed in accordance with company policies and regulatory requirements.
About the Role:
- Support equipment, facilities and utilities qualifications.
- Develop validation lifecycle documents and protocols/reports in accordance with relevant policies, standards, procedures and guidelines.
- Manage qualification execution and lead deviation investigations encountered during qualification.
- Collaborate with multiple functions to arrange and plan smooth running of qualification activities.
- Participate in site validation maintenance programs.
- Support change implementation on site.
Key Requirements:
- You should have an engineering or science degree from a recognized institution.
- A minimum of 2 years of experience in equipment qualification in the pharmaceutical/biotech industry is required.
- Experience in critical utilities, process equipment and facilities qualification is preferred.
- Temperature chamber qualification with temperature mapping experience is essential.
- Good knowledge and experience of practical and theoretical requirements of validation programs in GMP facilities is necessary.
- Good understanding of upstream, downstream and support services equipment within the pharma biotech industry is required.
- You should possess good oral and written communication skills.
- Meticulous and systematic approach is required.
- A team player with a strong focus on safety, quality and timeline is necessary.
What We Offer:
- GMP/cGMP knowledge is a plus.
- Self-motivated and capable of working in diverse teams with positive attitude towards project challenges.