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QA Specialist (all Genders)

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Bayer

Jan 12

Applications are closed

  • Job
    Full-time
    Mid & Senior Level
  • Healthcare
  • Berlin

Requirements

  • You have a completed university degree in pharmacy as well as a pharmacist's license
  • You bring good knowledge of regulatory requirements, particularly the EU GMP Guide
  • You have solid MS Office skills
  • You demonstrate strong organizational abilities
  • You possess assertiveness and clear verbal and written communication skills
  • You show initiative and work reliably and meticulously
  • You are resilient, flexible, and enjoy working in a team
  • You have excellent German language skills and good English language skills

Responsibilities

  • You will be responsible for overseeing the production lines in the packaging of parenterals and solids
  • You will create and manage deviations, conduct root cause analyses, evaluate them, and initiate corrective actions in close collaboration with production and quality assurance (QA)
  • You will assess the necessity of validation activities and lead, accompany, and coordinate these until completion
  • You will develop and evaluate validation and testing plans
  • You will create standard operating procedures (SOPs) related to qualification and validation
  • You will be responsible for the preparation, completion, and management of change requests in pharmaceutical affairs (Change Management)
  • You will evaluate and document process flows from a regulatory perspective and initiate and implement necessary compliance improvements
  • You will collaborate in the development of qualification and validation master plans

FAQs

What are the primary responsibilities of a QA Specialist at Bayer?

The primary responsibilities include overseeing production lines in the packaging of parenterals and solids, managing deviations, conducting root cause analyses, leading validation activities, creating standard operating procedures (SOPs), managing change requests, and evaluating process flows from a regulatory perspective.

What qualifications are required for this position?

A completed university degree in pharmacy and a pharmacist's license are required, along with good knowledge of regulatory requirements, particularly the EU GMP Guide, solid MS Office skills, and strong organizational abilities.

Is proficiency in languages required for this position?

Yes, excellent German language skills and good English language skills are required for this role.

What kind of work environment does Bayer promote?

Bayer promotes an inclusive work environment that embraces diversity, encourages employees to bring their whole selves to work, and supports professional growth.

What benefits are offered to employees at Bayer?

Bayer offers a competitive compensation package, support for childcare and eldercare, access to learning and development opportunities, health awareness initiatives, and many other benefits tailored to employees' lifestyles.

Is experience in teamwork important for this role?

Yes, the ability to work in a team is crucial, as flexibility, resilience, and collaboration are emphasized in the role.

What is Bayer's approach to employee development?

Bayer supports professional growth by providing access to learning and development opportunities, training programs, development dialogues, coaching, and mentoring programs.

Where is the QA Specialist position located?

The QA Specialist position is located in Berlin, Germany.

What is the company culture like at Bayer?

The company culture at Bayer is driven by energy, curiosity, and dedication, focusing on solving global challenges by harnessing diverse perspectives and continuously learning from one another.

Science for a better life

Science & Healthcare
Industry
10,001+
Employees
1863
Founded Year

Mission & Purpose

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power. Our products help address some of today’s biggest challenges, including global population growth, an aging society and the need to make efficient – and, wherever possible, sustainable – use of natural resources. In line with our mission “Bayer: Science For A Better Life,” we aim to improve people’s quality of life by preventing, alleviating or curing diseases. We also help provide an adequate supply of high-quality food, feed and renewable plant-based raw materials. For these endeavors, we focus on developing and successfully commercializing innovative products and solutions based on scientific knowledge.

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