Key Responsibilities
Document Review: Conduct thorough reviews of essential documents against Standard Operating Procedures (SOPs) to ensure accuracy and adherence to regulatory and internal guidelines.
Validation Support: Provide expertise and support during the development or modification phases of manufacturing facilities, systems, processes, and computerized systems to ensure they meet all applicable quality assurance requirements.
Quality Perspective Review: Assess and verify the validation approach and documentation to ensure compliance with procedures and regulatory submissions from a quality perspective.
Project Development Oversight: Ensure that the validation documentation for project development is thorough and supports regulatory submissions, maintaining a focus on quality assurance.
Qualifications:
- Bachelors of the arts / Bachelors of Science degree in the fields of Engineering or Science.
- 5+ years of relevant Job Experience
Preferred Qualifications:
-Proficiency in executing Pharmaceutical/Biotech Validation.
-Extensive knowledge of FDA regulations and GxP's.
- Must possess relevant experience or advanced training and exhibit proficiency in areas such as validation, change control, statistical methods (e.g., six sigma training), problem analysis and resolution, design of experiments, and process development/pilot scale work.
Benefits:
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
