Sr. Specialist Change Control Management

## We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
## Our Team, Your Impact
This section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we’re in it together, and we make work fulfilling.
## How You’ll Spend Your Day

- Ownership of the Change control process for Agile (Raw materials and other)
- Responsible for monitoring and following up on the status of the Change control through the lifecycle and assuring completion of all associated change activities throughout the execution and implementation of the change
- Investigation and system data correction relevant for batch release
- Monitoring and comparison of the approved master data with the factual data for all products with batch releaser EMSO Quality European Gx Bulgaria
- Presetting of regulatory data for maintenance in SAP and comparison of different data bases as SAP, Global Insight, GRIDs, TrackWise, MDG
- Elaboration of all product related pharmaceutical data, e.g. bulk manufacturer, packager, API manufacturer, shelf life, storage advice) as basic operational information
- Quality oversight of API when Teva procures the API according to the QTA
- Qualification and requalification of API manufacturers
- Audit planning
- Deviations related to Raw materials
- QTA initiation or updates request
- Evaluation of changes related to Raw materials

## Your Skills and Experience

- Minimum 07 – 10 years of experience in pharmaceutical industry
- M. Pharm / M.Sc. (Science), Pharmaceutical Sciences / Life Sciences
- Knowledge of cGMP, Quality management Systems and pharmaceutical manufacturing,
- Experience in product lifecycle management and continuous improvement
- Good knowledge of pharmaceutical quality systems, regulatory framework and GMP
- Hands on experience on Veeva or Trackwise systems and SAP
- Regulatory Affairs experience is an advantage
- Makes timely, informed decisions that consider the facts, goals, constraints and risks.
- Takes personal responsibility for the quality and timeliness of work and achieves results with little oversight.
- Adapts to changing business needs, conditions and work responsibilities and flexible thinking
- Manages own time, priorities and resources to achieve goals.
- Promotes organizational mission and goals and shows the way to achieve them
- Good communication skills – Verbal & written, this role being deals with external CMOs.

## Also Good to Have

## Salary Range

## How We’ll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.  When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. 
## Already Working @Teva?
Make sure to apply through our internal career site on Twist—your one-stop shop for career development
## Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.