Teva Quality Assurance Auditor 

United States, North Carolina 

516615740

• Compliance with Internal Audit Program schedule
• Generate, Collect and Upload Monthly & Quarterly Metrics for Quality Council and Site Quality Risk Map
• Prepare supporting documentation, facilitate and attend the Site Quality Council, present area results and prepare meeting minutes
• Prepare Site Quality Councils presentation on time
• Provide High quality support for Compliance CAPAs and investigations. Help develop and conduct the site Internal Audit Program.
• Provide support during Teva’s GRA Audits, Third Party Audits and outside Regulatory Inspections (e.g. FDA, MHRA, EU, Anvisa, etc.).
• Provide support to Site Inspection Readiness activities.
• Support Complaint investigations
• Assign, monitor and close audit and Compliance CAPAs in the Quality System.
• Perform gap assessments to ensure compliance with regulations.
• Provide support for site investigations.
• Prepares and submits reports, standards, and other documents as required.
• Engage in and promote Quality & Operational Excellence.
• Coordinate with other departments and perform investigations, and process change controls.
• Prepare APR contributions for complaints, investigations to show product performance and determine compliance
• Coordinate with other departments to complete investigations and reports
• Review and approve protocols, reports and change controls
• Provide guidance and coaching to employees on GMP, inspection readiness and quality systems
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies, procedures, state, federal and local laws, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions.
• Responsible for performing additional related duties as assigned or required by business needs.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires Bachelor’s Degree in Science, Engineering or related field from an accredited college or university.
• Minimum of five years relevant progressive QA experience in the pharmaceutical or a related industry or an equivalent combination of education and experience
• Requires experience in a solid dose manufacturing environment.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations, and CAPA's.
• Experience with Manufacturing/Quality systems such as TrackWise, Glorya, Veeva, LIMS/Labware, SAP, Learning Management Systems and statistical software preferred.
• Knowledge of CGMPs, SOPs, FDA, and other regulatory compliance regulations and standards required
• ASQ/CQE/CQA Certification preferred.

Skills/Knowledge/Abilities:
• Strong Project Management and organizational skills.
• Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions.
• Responding to technical inquiries from management, peers, and regulatory agencies.
• Operating scientific and personal computers.
• Managing multiple projects, duties, and assignments.
• Interpreting and applying Federal, state, and local policies, procedures and regulations.
• Establishing and maintaining cooperative working relationships with others.
• Pharmaceutical principles, practices, and their application.
• FDA, SOP, cGMP and other pertinent regulatory compliance and requirements.
• Pertinent Federal and State laws related to personnel administration.
• Business English usage, spelling, grammar, and punctuation.
• Principles of safety, worker’s compensation, OSHA, and related principles and practices.
• Business, scientific and personal computer hardware and software applications.
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel, Teams and SharePoint.
• Must be able to maintain the highest levels of confidentiality, integrity and discretion.
• Excellent verbal, written, and interpersonal skills required.

Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
• Able to identify solutions to general problems through collaboration and creativity.

TRAVEL REQUIREMENTS
• N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.