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QA Validation Engineer

Date Posted: February 23, 2024

Job Description

We are currently seeking a detail-oriented and experienced QA Validation Engineer to join our Quality Assurance team. In this role, you will be responsible for ensuring that all equipment, systems, and processes meet the required standards for quality and regulatory compliance. Your expertise in validation will be crucial in maintaining the integrity of our manufacturing processes and ensuring the production of high-quality pharmaceutical products.

Key Responsibilities

  • Develop, implement, and maintain validation protocols for equipment, systems, and processes within the pharmaceutical manufacturing environment.
  • Coordinate with cross-functional teams to perform validation activities, including but not limited to equipment qualification (IQ, OQ, PQ), process validation, and computer system validation (CSV).
  • Ensure that all validation activities are conducted in accordance with cGMP guidelines, FDA/EMA regulations, and other relevant regulatory standards.
  • Analyze validation test data to determine whether systems or processes meet acceptance criteria.
  • Identify and address potential risks in product quality or regulatory compliance through proactive validation strategies.
  • Prepare and review validation documentation, including validation plans, protocols, reports, and risk assessments.
  • Provide technical support and guidance to production and engineering teams on validation requirements and best practices.
  • Stay abreast of regulatory updates and industry best practices in validation to ensure continuous compliance and improvement.

Required Qualifications and Skills

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Minimum of 3 years of experience in QA validation within the pharmaceutical industry, with a strong understanding of validation principles and practices.
  • Proficient knowledge of cGMPs, FDA/EMA regulatory guidelines, and other international regulatory requirements applicable to pharmaceutical validation.
  • Experience with various types of validation, including equipment qualification, process validation, and computer system validation (CSV).
  • Strong analytical skills with the ability to interpret complex data and make informed decisions.
  • Excellent documentation and technical writing skills to prepare clear and concise validation documents.
  • Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Detail-oriented with a commitment to accuracy and quality.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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