Auftragsdetails

This is a contract position for seasoned auditors to conduct a variety of audits, both domestic and global, in accordance with FDA and other regulatory standards.  Expertise in Pharmacovigilance required.

• Provide support to clients on quality issues such as OOS results, deviations and non-conformances.
• Provide Quality oversight of operations and data review for accuracy, completeness, and conformance to current Good Pharmacovigilance Practices (cGVP) and company quality standards.
• Provide training, executing audits, document creation, communication, and oversight to meet the established quality goals of the client and applicable regulations.
• Provide assistance in performing internal and external GVP compliance audits and annual quality review.

Qualified candidates must have:

• Qualified candidates will possess a Bachelor’s degree in scientific or engineering discipline along with 5 plus years related industry experience.
• Experience in effective and results orientated project leadership.
• Excellent communication and strong interpersonal skills:
  • Able to liaise and negotiate efficiently with client companies to ensure the client needs are met.
  • Able to work within a team in an open and professional manner.
  • Able to liaise and negotiate efficiently with internal departments to facilitate delivery of services.
  • Ability to influence change.
• Experience providing support to clients with quality issues such as OOS results, deviations and non-conformances. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
• Ability to write and revise Standard Operating Procedures.
• Carry out duties and responsibilities with limited supervision.
• Flexibility to work occasional weekends and evenings.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
• Ability to plan and manage own work.
• Must be willing to travel regionally and/or nationally throughout the US.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
 

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***