Microbiological Innovation Management and CMO/CTL Support
Job ID SR0040334 Date posted 10/01/2019 Location Vienna, Austria
- Leads, owns and drives strategic global (multi-site, multi-product) microbiology/aseptic programs, initiatives and improvement activities
- Leads and/or supports Contamination Investigations (Rapid Response) on-site or remote
- Leads and drives network-wide Contamination Control Program
- Identifies, drives and aligns implementation of new technologies (Rapid Microbiological Methods - RMM)
- Leads network-wide microbiology/aseptic/RMM related Communities of Practice, drives knowledge management and represents Takeda in microbiology related forums, seminars, platforms, conferences, and publications
- Supports sites regarding microbiology/aseptic related challenges and questions
- Organizes and facilitates subject specific Global Communities of Practice calls/meetings
- Ensures alignment regarding compendial requirements and guidance by developing, and maintaining global procedures on environmental monitoring and critical utilities, cleanroom management and design, microbiological methods (including validations), sterilization and aseptic processing controls, etc.
- Responsible for Audit Support on-site and remote and for reflecting any lessons learned in the course of audits into global procedures (as applicable)
- Responsible for assessing critical CMO/CTL deviations
- Responsible for providing micro/aseptic related submission support as needed
- Assures cost savings by alignment of global disinfectant efficacy studies
- Interaction with different Health Authorities in the course of inspections as needed
Your Skills and Qualifications
- A minimum of 5 years of experience in a GMP-environment within the pharmaceutical industry as strongly required
- A minimum of 3 - 4 years in a microbiology laboratory or comparable, such as in a sterility assurance function are typically required
- Profound knowledge and experience in microbiology
- Experience in contamination investigations
- Leading and/or supporting investigations of contaminations or e.g. issues with microbiological methods on-site and/or remote (e.g. rapid response)
- Excellent communication, interpersonal and organizational skills
- Proactive at keeping current with literature and latest technologies
- Ability to work well both independently and in a team environment
- Conducts work in compliance with cGMPs, safety and regulatory requirements
- Experience in working with strategic initiatives
- Experience in providing audit support (either remote or on site)
- Expertise to lead alignment and compliance regarding Environmental Monitoring, Monitoring of Critical utilities, Sterilization and Aseptic Processing Controls, Cleanroom Gowning, Cleanroom Management, etc.
- Ability set priorities and to support facilities throughout the global network
At Takeda, we are transforming the pharmaceutical industry through our R&-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0040334
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