One of the top Pharmaceutical Manufacuters in Swiftwater, PA is looking to hire a Compliance Speciaist to join the team!
The compliance specialist will have these priorities listed:
Priority 1 - Continued Process verification. Evaluate Sites and harmonize practices based on the global CPV documentation
Priority 2 - Process Criticality Assessment (from Quality by Design Principles). Evaluate sites and harmonize practices based on global QbD documentation
Priority 3 - Support global validation document revision
Priority 4 - Implementation of a risk-based approach for validation phase 2 PPQ.
Assist in organizing the priority task force meetings
Assist in performing the sites evaluation and assessments
Assist in the identification of the necessary remediation for each site
Follow up on action and ensure deliverables are met on time
Alert in case of roadblock or delays.
Provide input in validation document reviews.
Assist in organizing monthly review meeting with the Validation CoE members.
- Engineer/master degree, with 5+ years in quality validation.
- Risk-based approach / ICHQ9 mindset
- Vaccines & Biotech Processes understanding/knowledge
- Methodology ability
- High level of autonomy
- Excellent communication skills, able to manage cross functional communications
- Leadership during workshops / Experience in understanding customer's voice and quality requirements is a must
f you are interested in this Compliance Specialist in Swiftwater, PA then please click APPLY NOW. For other opportunities available at Modis Engineering and Technology go to www.modis.com. If you have questions about the position, please contact Ray Sabio at 317-558-8868 or Raymond.Sabio@modis.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/ The Company will consider qualified applicants with arrest and conviction records.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please
The Company will consider qualified applicants with arrest and conviction records