QC Lab Validation Engineer
Date Posted: April 25, 2024
Job Description
We are looking for a Lab QC Validation Engineer to oversee and implement validation activities related to pharmaceutical quality control processes. Your primary focus will be on validating methods and systems to ensure they are suitable for their intended purposes and meet all regulatory standards. You will be responsible for planning, conducting, and documenting validation work, including analyzing data and making recommendations for improvements to ensure ongoing compliance and quality in all Lab QC activities.
Key Responsibilities
- Develop and execute validation strategies for quality control methods and systems, ensuring they are appropriate for their intended purposes.
- Plan and conduct validation studies, including protocol development, testing, data analysis, and reporting.
- Collaborate with QC analysts, R&D, and regulatory affairs to ensure validation activities meet internal and regulatory requirements.
- Review and interpret validation test data, identifying trends and making recommendations for system or process improvements.
- Prepare and maintain comprehensive documentation for all validation activities, including validation plans, protocols, reports, and summary documents.
- Ensure that all QC validation activities comply with relevant regulatory standards, such as GMP, FDA, EMA guidelines, and ISO standards.
- Investigate and troubleshoot validation-related issues, implementing corrective and preventive actions as needed.
- Keep abreast of industry best practices, regulatory updates, and new technologies in QC validation.
- Provide training and guidance to QC staff on validation concepts, procedures, and documentation requirements.
Required Qualifications and Skills
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related scientific field.
- Minimum of 5 years of experience in Lab QC Validation within the pharmaceutical or a closely related regulated industry.
- In-depth knowledge of GMP guidelines, FDA/EMA regulatory requirements, and ISO standards relevant to pharmaceutical quality control.
- Proficiency in statistical data analysis and experience with statistical software.
- Strong technical writing skills for clear and concise validation documentation.
- Excellent problem-solving abilities and attention to detail.
- Effective communication and interpersonal skills, with the ability to work collaboratively across departments.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Experience with CSV.
- Familiar with Lab systems/ equipment qualification.
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
