Manager
Contract Pharmacal Corp. - Hauppauge, NY

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Help develop and maintain internal Quality System
  • Manage investigations and oversee written responses for Customer Product Complaints
  • Direct Change Control System
  • Prepare Annual Product Reviews for Drug Products
  • Direct Corrective Action / Preventative Action (CAPA) System
  • Support Compliance in customer and agency audits
  • Preparation and submission of Electronic Drug Product Listings to the FDA
  • Assist in review and preparation of Standard Operating Procedures (SOPs)
  • Assist in review and preparation of Process Validation Protocols and Reports
  • Analysis of customer and regulatory requirements to assess their effect on the internal Quality System
  • Handle customer inquiries regarding product status and ingredients
  • Participate in senior management meetings
  • Qualifications
    • Bachelor’s degree in science, business administration or related discipline
    • Minimum two years experience working in quality assurance or compliance for pharmaceutical company.
    • In-depth knowledge of current GMPs, document controls, and pharmaceutical production record review
    • Excellent oral and written communication skills
    • Self-motivated, seeking information from both internal and external sources with the ability to work in fast-paced environment and handle multiple tasks simultaneously
    • Solid computer skills
    • Excellent organization skills with the ability to focus on details
    • Demonstrate problem-solving ability using innovative thought and good judgment
    • Stable work history with previous employer references
    CPC is offering a professional, stable work environment with excellent opportunity for career growth in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, ife insurance, paid time-off, and 401(k) plan.

    Contract Pharmacal Corp. - 19 months ago - save job - copy to clipboard - block
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