ParaPRO Career Opportunity

Job Overview:

ParaPRO LLC is a new pharmaceutical company located in Carmel, IN and is a wholly owned subsidiary of SePRO Corporation. ParaPRO’s initial product offering, a pediatric medication for pediculosis capitis, has recently completed Phase 3 clinical trials and will be submitted to the FDA in 2008.  The Q&R Director will be a key driver in setting up the company for its first product launch in 2009 in a virtual company environment.

Job Responsibilities Include:

• Developing and implementing a Quality System
• Developing the Quality Manual and SOPs
• Organizing the documentation library
• Dispositioning batches of drug substance and drug product
• Measuring and reporting quality metrics
• Preparing for regulatory interactions
• Conducting internal and external compliance audits

Currently regulatory compliance components have been managed by external contract organizations. These organizations will work with the Q&R Director to transition those activities.

Qualifications/Skills/Requirements:

• BS in Engineering or a Scientific discipline
• At least 5 years of experience in the pharmaceutical industry in Quality Assurance and Regulatory roles
• Documented knowledge and experience to develop a Quality System based on Federal, State and International regulations for pharmaceutical manufacturers
• Understanding of product development, manufacturing, sourcing, and servicing in the pharmaceutical environment
• Experience working with key suppliers to provide ‘turn key’ product development solutions
• Effective report, business correspondence and procedure-writing skills
• Effective process development and project management skills
• Knowledge of pharmaceutical terminology
• Ability to compile and submit required documents to FDA (i.e. IND, NDA, meeting requests, clinical trial reports)
• Experience with post-marketing requirements
• Good problem identification, analysis and solving skills
• Strong computer and e-skills
• Lead Auditor certification and/or Regulatory Affairs Certification a plus

Ability to travel is required. The chosen candidate will travel to contract manufacturing, research, and supply organizations as required by the QA/QC components of the job. The primary regulatory consulting agency is located within walking distance of ParaPRO headquarters.

Benefits Include

• Health Insurance
• Life Insurance
• Dental/Vision Insurance
• 401(K) with 25% company matching
• Additional Profit sharing via  401(K)
• Access to medical/daycare pre-tax savings
• Access to short-term and long-term disability insurance
• Paid Vacation and Holidays

Please submit your resume and cover letter via email to Bill Culpepper III, Director of Corporate Development: bill3@parapro.com.

As with all employment application materials, receipt of such information does not obligate SePRO/ParaPRO to review or otherwise use such information.