The Sterility Assurance Expert Filling and Lyophilisation will serve as a subject matter expert and will be responsible for Sterility Assurance of sterile products manufactured in Filling & Lyophilisation production area.
The subject matter expert will provide leadership in training, development and empowerment of individuals in the area of responsibility to achieve business objectives related to quality with focus on Sterility Assurance.
In addition, this role includes managing relationships with local and global Quality Assurance Sterility Assurance functions and respective network.
Main areas of responsibility are:
- Planning, coordination and supervision of aseptic process simulations (APS)
- Routinely supervision of shop floor to review, train and develop operators related to hygiene behaviours and aseptic techniques
- Assess, revise, review, approve and be owner of local standard operations procedures (LSOP) with potential impact on Sterility Assurance
- Single point of contact for end-to-end accountable senior manager for Sterility Assurance related topics
- Contributes as a member of expertise network to the harmonization and continuous improvement of sterility assurance knowledge and practices on site
- Review and approval of quarterly environmental monitoring trending reports
- Owner of monitoring trending meeting to ensure excellent environmental and personal monitoring performance
- Facilitate and lead improvement initiatives related to but not limited to cleaning and disinfection, sterile wrapping of equipment, environmental monitoring programme and aseptic process simulations
- Subject matter expert for Sterility Assurance when production area is under inspection or audit
- Prompt escalation of sterility assurance issues and concerns in the production area
- Min. of Bachelor’s degree is required, a focused degree on in a Science-related discipline like Microbiology is preferred. An advanced degree like a Master’s or PhD is preferred
- Must have an understanding of vaccines/biologic products and associated technologies, sterility assurance and associated techniques
- A min. of 5 years’ experience in a cGMP controlled/pharmaceutical industry
- 3-5 years’ experience/knowledge of: cGMPs and regulatory requirements, contamination control, disinfection techniques, sterility assurance, aseptic processing
- Maintain knowledge of regulatory environment and requirements with regard to sterility assurance and aseptic processing
- Fluent in German required as well as good spoken and written English is preferred
- Excellent analytical, prioritization, communication and leadership skills required
as described above
GlaxoSmithKline is a world-leading, research-oriented healthcare company committed to developing innovative pharmaceuticals.
We are also the largest producer of vaccines in Germany.
Our goal is to improve people’s quality of life by enabling them to live longer, healthier, and more actively.
This challenge is in the hands of our employees. Everything depends on their commitment.
As a strategic location for GSK Vaccines, an international market leader in vaccine research & production, our business can look back over more than 110 years of tradition. In the attractive university town between Kassel and Frankfurt, we are working on keeping people healthy by developing vaccines and thus following in the footsteps of our company’s founder and the first Nobel Laureate in medicine, Emil von Behring.
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
For our Global Sourcing Department in Marburg we are looking for a: Category Manager (f/m/d) - R-080531 (Fulltime / non-tariff) The Indirect Sourcing Category Manager will effectively take a...
Senior Talent Acquisition Consultant - Marburg Main Responsibilities and Accountabilities Translate business needs (from talent reviews, business plans and growth strategies) into talent...
Our Legal Department in Marburg is looking for a: Senior Counsel, R&D and Corporate Development Senior counsel responsible for providing legal support primarily to CSL Behring’s global R&D and...
For our Functional Unit Site Supply Chain Marburg we are looking for a Head of Planning (f/m/d) - R-077831 (fulltime/ permanent/ non-tariff/ location: Marburg) Position Purpose The Head of...
For our PACE Project we are looking for a RSPL OTC Europe Order Mgmt and Customer Service and RSPL Customer Mgmt (f/m) (fulltime/ permanent/ non-tariff/ location: global) Position Purpose PACE is...
Für die Abteilung Quality Bulk and Release QBR suchen wir ab dem nächstmöglichen Zeitpunkt einen Quality Manager Active Substance (m/w) (Vollzeit / befristet bis 31.12.2020 / Außertarifliche...
For our Global Sourcing Department in Marburg we are looking for a: Category Manager (f/m/d) -...
Senior Talent Acquisition Consultant - Marburg Main Responsibilities and...
Our Legal Department in Marburg is looking for a: Senior Counsel, R&D and Corporate...
For our Functional Unit Site Supply Chain Marburg we are looking for a Head of Planning (f/m/d)...
For our PACE Project we are looking for a RSPL OTC Europe Order Mgmt and Customer Service and...
Für die Abteilung Quality Bulk and Release QBR suchen wir ab dem nächstmöglichen Zeitpunkt...