What are the responsibilities and job description for the Validation Specialist - Serialization and Compliance position at Apozeal Pharmaceuticals Inc.?
Overview
We are seeking a highly organized and detail-oriented Validation Specialist to join our Pharmaceuticals team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and company standards for product serialization, equipment qualifications, validations, calibrations, change control, and SOP management. The ideal candidate will have a strong understanding of GMP regulations and experience with serialization processes.
Duties
- Manage product serialization processes, ensuring compliance with regulatory requirements and company standards
- Perform equipment qualifications, validations, and calibrations to ensure accuracy and precision
- Develop, review, and approve SOPs, protocols, and other quality documents.
- Implement and manage change control processes, ensuring minimal disruption to operations.
- Coordinate with various departments to ensure compliance with GMP regulations.
- Conduct investigations and root cause analysis for deviations and non-conformances.
- Maintain accurate records and reports, ensuring data integrity and traceability.
- Collaborate with cross-functional teams to implement process improvements.
- Proper material management and handling of returns.
Requirements
- Bachelor's degree in Pharmacy, Engineering, or related field
- 2 years of experience in pharmaceutical industry, preferably in validation or quality assurance
- Strong knowledge of GMP regulations and guidelines
- Experience with product serialization and track-and-trace systems
- Excellent organizational, communication, and project management skills
- Attention to detail and ability to work in a fast-paced environment
Preferred Qualifications:
- Certification in validation or quality assurance (e.g., CQA, CQP)
- Experience with industry-standard software and systems (e.g., serialization software, MES)
- Knowledge of risk management and FMEA methodologies
Pay: From $40,000.00 per year
Benefits:
- Paid time off
Work Location: In person
Salary : $40,000