Aseptic Processing & Sterility Assurance Lead (f/m/x)
Takeda
Vienna, Austria
vor 5 Tg.

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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 ( 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.

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 € ,92 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

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

More about us :

At , 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.

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