Aseptic Processing & Sterility Assurance Lead (f/m/x)


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Job Description

About the role:

in this role you will be designing, implementing and driving a network wide (multi-site, multi-product) aseptic and sterility assurance program across Takeda facilities. Driving standardization, harmonization and best practice across sterile manufacturing operations/sites and providing training/capability building concerning aseptic processing and sterility assurance throughout the Takeda network will also be a vital part of your tasks. You will also be delivering and driving continuous improvement of aseptic techniques/partices to assure the sterility of Takeda products. This role also embraces evaluating and certifying Takeda sterile manufacturing sites to ensure aseptic practices and techniques are aligned with Takeda´s global aseptic standards and compendial requirements.

How you will contribute:

  • Indepth knowledge and expertise in aseptic processing and sterile operations to assure adoption of best practice in aseptic processsing across the Takeda network

  • Provide support (on site and remote) to the Takeda sterile manufacturing site on all aspects of aseptic processing/behaviours and sterility assurance

  • Provide advice/guidance and training for personnel to enhance aseptic practices and sterile production processes

  • Ensure alignment of Takeda´s manufacturing network with the global microbiological/aseptic standards and compendial requirements

  • Oversee implementation of global procedures on sterilization and aseptic processing (e.g.aseptic process simulations, disinfectant efficacy studies, gowning, aseptic behaviour etc)

  • Support Health Authority inspections on-site and remotely and incorporate any lessons learned in the course of inspection into the relevant global procedures

  • Provide support to Takeda´s sites regarding aseptic related challenges

  • Execute a holistic end to end program to evaluate and certify Takeda sterile manufacturing sites in aseptic processing and to assure the sterility of Takeda products

What you bring to Takeda:

  • Bachelor’s Degree in Microbiology, Pharmaceutical Science or equivalent, Masters degree is a plus.

  • Minimum of 10 years professional working experience in pharmaceutical manufacturing, Quality Control Microbiology, Quality Assurance or related compliance experience with at least 5 years managing audit processes for GMP / GDP, ISO and ICH, and at least 5 years’ experience supporting FDA, EMA, PMDA and/or other regulatory health authority inspections.

  • Strong/in-depth aseptic background.

  • Deep knowledge of aseptic behavior and sterile/aseptic processing (different formulation, vials, ampoules, vaccines)

  • Knowledge of different pharmaceutical manufacturing technologies

  • Ability to influence and work effectively across various regions and cultures.

  • Strong interpersonal skills including listening, judgment, conflict management, ability to lead teams in a global environment.

  • Proven leadership in managing risks and resolving conflicts to achieve positive outcomes.

  • Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.

  • Demonstrated collaboration within and across functions, initiative and problem-solving skills.

  • Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English and regional languages as needed.

  • Ability to travel

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 4.751,92 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

  • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten

  • Work @ home depending on the position / department

  • Comprehensive training programs

  • In-house job rotation program

  • In-house Canteen with discounts or meal vouchers

  • Works council (events, festivals, shopping vouchers, etc.)

  • Employee Referral Program

  • Employee Recognition Program

  • Takeda Resource Groups

  • Medical checkups

  • Free vaccination program

  • Fitness Center

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations

AUT - Wien - Industriestrasse 67

CHE - Glattpark (Opfikon) - Zurich HQ

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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