Vacancy as Associate Manager (Regional Delivery Microbiologist)–QA in Procter & Gamble
Procter & Gamble is the innovation leader in our industry. Virtually all the organic sales growth we’ve delivered in the past nine years has come from new brands and new or improved product innovation. We continually strengthen our innovation capability and pipeline by investing two times more, on average, than our major competitors.
P&G. We interact with more than five million consumers each year in nearly 60 countries around the world. We conduct over 15,000 research studies every year. We invest more than $350 million a year in consumer understanding. This results in insights that tell us where the innovation opportunities are and how to serve and communicate with consumers.
Post: Associate Manager (Regional Delivery Microbiologist)–QA - MFG00003270
The Regional Delivery Microbiologist provides the regions Manufacturing operations with the necessary microbiological expertise to make them self sufficient and capable to dealing with new initiatives, products and microbiological incidents rapidly and appropriately. They will assure that the current methodologies for microbiological evaluations and testing are implemented across the region and will report to the regional micro leader
Key role deliverables
* Establishing and leading a regional site microbiology network to support capability building, risk management and troubleshooting at product supply and starting material sites
* Selection training and qualification of the site microbiologists.
* Leading and maintaining the development of the microbiological capability at manufacturing sites.
* Providing leadership and expertise to PS and QA to minimize business losses associated with microbial contamination
* Ensuring the transition of all initiative related micro issues or concerns to manufacturing site/s.
* Become the single point of contact for a specific BU or technology
* Train and qualify the sites in new microbiological test methods
* Review site data and manage regional scorecards and metrics
1) Technical coaching to manufacturing sites within the region - specifically site microbiologist's pproviding the source of microbiological expertise, training and input to plants helping the plant/site microbiologists to build capability within their own organizations.
2) Selection, training and qualification of site microbiologists
3) Responsibility for microbiological compliance across the region and the establishment of a strong network of connections within the P&G microbiological community
4) Review and advise on the implementation and rigor of the individual sites daily management programs
5) Co-ordinate the sites testing programs and data acquisition system to provide a regular and detailed status of the regions microbiological performance assuring consistency of standards across sites. Review and monitor MDM data for region and guide sites on the effectiveness of their overall MDM program to assure alerts and actions are managed effectively as prevention tools
6) Conduct regular integrated Microbiological risk assessments at each site and be able to help the site develop effective correction and risk mitigation plans. Assure communication the identified risks to the business/es and leadership to ensure understanding and transparency of the risks associated with microbiology.
7) Drive root cause investigations to help rapidly resolve any contamination incidents in any of the sites within the region to minimise consumer risk, cost, supply disruption and. Ensure that any learning's resulting from the incident are rapidly deployed and implemented in both the sites within the region and globally.
8) Provide technical concurrence to all OOS product dispositions and provide input to short-term and long-term solutions to leadership. Help in the identification of all contaminant organisms and provide expert advice and recommendations to QA, operations and PS&RA relating to the disposition of contaminated product.
9) Provide training and guidance on validations to facilitate solid technical, science based rationale for various approaches and/or deviations
10) Provide sites with the capability to assure compliance with the local/regional regulatory requirements participate in internal and external regulatory audits as required.
11) Provide a robust linkage between the plant and the relevant Micro design groups to assure the smooth transmission of information and methodologies required to reduce the microbiological risks. Including any required pharmacopeia or regulatory testing.
12) Aid in the sites development and approval of robust required cleaning and sanitisation procedures. Review the completeness/ and rigor of the individual sites cleaning and sanitisation validation protocols and programmes.
13) Provide the regional engineering and initiative groups with expert guidance on all microbiological aspects of a proposed designs or modification. Act as the technical liaison between R&D and PS organizations.
We look for candidates who have a passion for winning and who have demonstrated excellence in their work and academic experience. We look for people with leadership skills who are effective in teams. We want employees with strong analytical skills and the ability to think of out-of-the box solutions to business problems. We want people who are able to handle multiple priorities, who have a bias for action and who are genuinely interested in personal development and the development of others. Finally, we want people who would respect and embody the Principles and Core Values that make P&G the organization it is.
*Masters Degree or post-graduation (MSc/ PhD) in biology, microbiology, biochemistry, medical technology or related field required. Familiarity and work experience in isolating and identifying microorganisms, microbial ecology, cleaning and sanitization techniques, clean design and contamination investigations
*Strong , demonstrated knowledge of Microbiology systems, resources and organizations demonstrated by having lead a microbiology organization.
*Demonstrated capability to assess, develop and implement micro risk management strategies within manufacturing or supply operations including the initial development and ongoing revisions of daily management programs, micro risk assessment and mitigation strategies.
*Ability to build technical capability in plant resources at all levels including transfer of methods, troubleshooting skills, equipment design and investigative skills
*Demonstrated capability to troubleshoot issues with existing products and processes to root cause, and to identify and implement systemic fixes.
*Ability to translate complex issues into a meaningful set of recommendations that can be understood by non-microbiologists.
*Ability to assess the impact of new processes or product initiatives on the region/site and to develop or implement appropriate plans (i.e. change control follow up, SOP revisions, validation requirements).
*Demonstrated capability to lead work across multiple categories/ Business units in order to develop and implement standard approaches. * Ability to influence those outside his/her own function in order to align on common work practices.
*Strong communication, leadership and influencing skills across all levels of the organization
*Proven track record of establishing effective training programs for microbiology across organizations
*Understanding of appropriate regulatory and compliance requirements for the site/region
Education: M.Sc, Ph.D - biology, microbiology, biochemistry, medical technology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production
Job Code: MFG00003270
End Date: 20th May, 2012
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