Minimum of 8 years' experience in Quality Control/ Quality Assurance in a pharmaceutical manufacturing environment.
ASQ CQA certification preferred. Proven personnel and project management history.
Complete knowledge of FDA Code of Federal Regulations (CFR) and International Conference Harmonization (ICH) guidelines, pharmaceutical regulations including current GXP, GLP, or GMP requirements
Preferred Skills/Qualifications:
Excellent communication and leadership skills.
Ability to work in and promote a team environment.
Working knowledge of Six Sigma and/or Lean manufacturing tools.
Complete understanding and application of principles, concepts, practices, and standards within discipline.
Ability to lead and influence people.
Understanding of basic statistical principles
Expert knowledge of cGMP guidelines and knowledge of US and International pharmaceutical manufacturing regulations.
Bias toward change, management of change, and achievement of results
Exercises considerable latitude in determining technical objectives of assignment
Demonstrated ability to make risk-based decisions regarding product quality and regulatory compliance
EEO Statement:
Benefits
Health insurance
Additional Information
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Job Description Summary
SUMMARY OF POSITION:
Provides overall Quality Assurance (QA) management of the batch record review, manufacturing (current Good Manufacturing Practices) cGMP compliance, and product release functions for the manufacturing of pharmaceutical products. Provides QA and cGMP compliance leadership regarding Quality systems and adherence to site, corporate, and regulatory requirements. Key leadership position within the Quality group.
Job Description
Provides overall Quality Assurance (QA) management of the batch record review, manufacturing (current Good Manufacturing Practices) cGMP compliance, and product release functions for the manufacturing of pharmaceutical products. Provides QA and cGMP compliance leadership regarding Quality systems and adherence to site, corporate, and regulatory requirements. Key leadership position within the Quality group.
ESSENTIAL FUNCTIONS :
Manage the QA team responsible for batch record review, product release, label issuance, sampling and sample management activities
Write, review and approve exceptions, change controls, and CAPA in the quality system.
Review and approve out of specification and customer complaint investigations in quality system.
Lead strategic Quality continuous improvement efforts and projects
Provide expertise to support site transition to align with drug product expectations
Lead auditor for the site internal audit system
Follow all internal and basic cGMP guidelines for pharmaceutical operations
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal polices to assure compliance
Ability to identify, evaluate and remediate gaps as they pertain to data integrity
Provides solutions to technical problems of moderate scope and complexity
Adhere to all safety rules and maintain 100% completion of all safety required training
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS :
MINIMUM REQUIREMENTS :
Education:
BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.
Endo Pharmaceuticals · Greenville, IL (pharma) - Usa034