Interface with Global & Divisional Quality/Microbiology teams to provide input on programs, procedures and methods
Obtain approval for exemptions to the Micro Approval Process (MAP)
Support the implementation of global programs on a divisional basis e.g. Celsis, training programs and tools.
Present divisional/regional challenges to Global Microbiology and other GTCs. In partnership with Global Microbiology, other GTCS and other individuals, lead effort to find solutions to regional challenges.
Participate in internal audits (including microbiology laboratory) and external audits (contract manufacturers & labs, suppliers, etc.) Function as part of the Divisional Quality Team.
Support Regional Technology Center:
Support the product development process:
Partner with product development groups to improve formula robustness.
Provide guidance on raw material micro susceptibility and required information on methods and specifications.
Lead the development and continuous improvement of the MAP according to category (and any regulatory) requirements and limitations.
Support the technology transfer process including appropriate microbiology training.
Review and approve protocols and test methods developed to support claims for regional products. Working with local CP regulatory, ensure that they will satisfy local regulatory requirements.
Review and approve protocols, SPIs (SOPs), reports, (deviations and exemptions where applicable) to thoroughly document all activities.
Rapid Micro Methods Program including Celsis and Charm
Interfaces with Global & Divisional Quality/Microbiology teams to provide input on programs, procedures and methods
Engages Site, Division and Manufacturing and Technology Management as necessary to provide appropriate leadership and resources to ensure full conformance to the Quality and Micro Control Standards.
Creates and nurtures practical networks (with Supply Chain, Technology, Legal & Regulatory departments) that foster teamwork and empowerment to strategically manage micro requirements
Strong analytical/decision making skills. Gathers information efficiently, analyses and trends data uses data to support recommendations.
Provides direction for improving microbiological control in the entire site facility.
Communicates information clearly, simply and in a timely manner. Good written & spoken English is a necessity.
Demonstrates the ability to apply continuous improvement tools to affect positive change (MSI, CPM, etc.).
Understands the linkages and interdependencies between the Product Development and Supply Chain processes (Tech Transfer).
Champions new initiatives
Stays abreast of external global business development
What you need for this position:
Bachelor's degree in Microbiology or related major. Must include significant coursework in Microbiology (four courses).
At least 10 years of industrial experience (Personal Care, Pharmaceutical, Food, and Environmental). This experience should include working in both laboratory and plant environments with exposure to micro control programs.
It s an advantage to have:
Master s degree or Ph.D.
Functional knowledge of standard QA testing (contamination checks, preservative effectiveness, and identification systems) is a definite plus.
Associated topics: aseptic, bacteria, biomedical, cytometry, drug development, drug discovery, medical, pharmaceutical, physiology, therapy
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.