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Boehringer Ingelheim Vetmedica.Inc.
Senior Specialist Auditing / Training
Job Location: Saint Joseph, MO
Department:
QA/QC / Other
Shift:
Full Time
Our Culture - Come Discover Us
In a world where business is driven by short term financial goals, Boehringer Ingelheim Corporation is truly a company with a different philosophy. Although we are one of the largest and fastest growing pharmaceutical companies in the world, we have been able to maintain a dedication to our values. Our focus is on helping patients, serving our customers and improving the quality of life for the millions of people who rely on us. Simply put, we have remained committed to doing the right thing-for our customers, our communities, our employees and everyone we serve.
At Boehringer Ingelheim, we realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to create a healthy working environment-meaningful work, diversity, mobility, networking and work-life balance. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, as well as our partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background checks and drug screenings.
QUALIFICATIONS:
- B.A. or B.S. degree in chemistry or microbiology or equivalent
- 5 or more years of experience in the pharmaceutical industry
- Experience leading audit teams
- Evidence of excellent written communication skills
- Professional credentials, which might include: Certified Quality Auditor (preferred), Certified Quality Systems Lead Audit, Certified ISO9000 Internal Audit, Certified GMP Trainer, Certified Quality Engineer
DUTIES & RESPONSIBILITIES:
- Manages all aspects of the external cGMP audit program for contract manufacturers, brokers, laboratories, raw material and packaging component suppliers, including: scheduling and execution of audits, reporting results, and follow-up to assure resolution of cGMP concerns.
- Manages all aspects of the internal cGMP audit program, including: scheduling and execution of audits, reporting of results, and follow-up to assure resolution of cGMP concerns.
- Administers the cGMP training program for new and current employees, including: development of training content, scheduling and conducting sessions with documentation of training for Pharmaceutical, Non-Pharmaceutical and Biological Manufacturing.
- Provides support to resolve quality-related concerns with contact manufacturers, including: providing support for validation, development and execution of protocols.
- Provides technical cGMP support and internal consulting to various manufacturing and other groups to assure continued and efficient compliance to regulatory requirements including: drafting SOP’s and batch records.
- Resolve quality concerns and implement quality improvements by meeting with other department Managers, Staff Managers to assure current methods, procedures or SOP’s meet current standards.
- Provides back-up assistance to Director, Quality and Compliance for audit responses to consultant and 3rd party audits (including FDA, EU, APHIS, etc.).
How To Apply:
Boehringer Ingelheim Vetmedica.Inc.
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