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Quality Assurance Validation Specialist
2 months ago
Position Overview:
As a key member of the Cambrex ESDT Validation Team, this role is responsible for coordinating and facilitating validation and qualification efforts related to manufacturing and analytical equipment. The individual will provide on-site execution support, monitoring, and updates to ensure compliance with validation standards and cGMP regulations.
Key Responsibilities:
- Validate and qualify GMP analytical instruments, equipment, utilities, and facilities.
- Develop and execute qualification and validation documentation (IQ, OQ, PQ) in alignment with Cambrex Corporate Policies and industry standards.
- Create Validation Plans, Validation Plan Summary Reports, Annual Validation Plans, and Annual Validation Review reports.
- Document validation activities throughout the lifecycle accurately and comprehensively.
- Assist in the development of specifications for equipment and systems as necessary.
- Collaborate with Manufacturing, Quality Control, Facilities, IT, and Materials Management to implement validation activities effectively.
- Engage with equipment vendors to ensure thorough documentation is collected during qualification processes.
- Stay informed about industry best practices and regulatory guidelines.
- Provide validation support during client and regulatory audits.
- Comply with all site safety protocols and guidelines.
Qualifications and Skills:
- Proven ability to work independently as well as collaboratively within a large cross-functional team.
- Strong organizational skills with the ability to prioritize tasks to meet deadlines.
- Capacity to understand equipment functionality and design suitable validation and qualification protocols.
- Ability to exercise sound judgment within established procedures to determine appropriate actions.
- Basic knowledge of pharmaceutical manufacturing processes and analytical equipment.
- Understanding of validation principles throughout the equipment lifecycle.
- Excellent organizational, interpersonal, verbal, and written communication skills.
- Familiarity with enterprise systems such as Blue Mountain Regulatory Asset Management System, Rees Environmental Monitoring System, and Master Control Document Management System is advantageous.
Educational Requirements:
- A Bachelor’s Degree or higher in a scientific discipline is required.
- 3-5+ years of experience in a GMP pharmaceutical environment, focusing on the validation and qualification of equipment, utilities, and facility systems.
This position offers a competitive benefits package.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
