QA Validations Specialist II
The Quality Validations Specialist II is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation activities. Specific responsibilities include reviewing SOP’s, and validation master plans; reviewing protocols for facility, utility, manufacturing equipment, cleaning and process validation projects; conducting reviews and approvals of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; monitoring compliance; reviewing and approving change controls for facilities, utilities, equipment and instruments; supports pre and post shutdown activities; review and approve facilities documentation including Calibration Forms, Work Orders and Preventative Maintenance records; participate in regulatory audits; and consulting on validation and cGMP questions and issues. The ideal candidate will work on complex problems with the Validation Group for analysis of situations or data requirements with in-depth evaluation of various factors.
- Performs the pre-approval qualification and validation of equipment and systems.
- Performs the final review and approval of executed qualification activities and associated documentation.
- Participates in capital project analysis for equpiment and facility upgrades.
- Provides judgment within defined procedures and practices to determine appropriate action.
- Serves as information resource for validation technicians, contractors and vendors.
- Drafts department SOPs and Training Modules.
- Reviews and approves SOPs and master validation plans.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Bachelor’s Degree with 4+ years of related experience.
- Strong knowledge of quality assurance reviews of validations documentation.
- cGMP training and strong understanding of requirements.
- Strong knowledge of pharmaceutical GMP environment.
- Strong understanding of and ability to utilize Pro Cal.
- Strong understanding of and ability to review and analyze Kaye Validator data.
- Strong understanding of Val Probes mapping data.
- Good understanding of and ability to utilize CAL MAN.
- Strong communication skills (oral and written), mechanical skills, and working knowledge of Microsoft Office applications.