# QA Specialist

**Company**: Bayer AG Pharmaceuticals
**Location**: Berlin
**Job type**: full-time
**Salary**: 77,300€ - 93,800€ per year
**Category**: Manufacturing
**Industry**: Healthcare

**Apply**: https://talent.bayer.com/careers/job/562949977395231?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6ab194d7-c3e

## Description

At Bayer, we're seeking a Quality Assurance Specialist to join our Pharmaceutical Affairs team in Berlin. As a QA Specialist, you will checkout production lines in the packaging of parenterals and solids, 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 also assess the necessity of validation activities and lead, accompany, and coordinate these until completion. Additionally, you will develop and evaluate validation and testing plans, create standard operating procedures (SOPs) related to qualification and validation, and be responsible for the preparation, completion, and management of change requests in pharmaceutical affairs (Change Management).

In this role, 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. You will work closely with production and quality assurance teams to ensure compliance with GMP standards.

Key responsibilities:

- Oversee production lines in the packaging of parenterals and solids

- Create and manage deviations, conduct root cause analyses, evaluate them, and initiate corrective actions

- Assess the necessity of validation activities and lead, accompany, and coordinate these until completion

- Develop and evaluate validation and testing plans

- Create standard operating procedures (SOPs) related to qualification and validation

- Prepare, complete, and manage change requests in pharmaceutical affairs (Change Management)

- Evaluate and document process flows from a regulatory perspective and initiate and implement necessary compliance improvements

- Collaborate in the development of qualification and validation master plans

Requirements:

- Completed university degree in pharmacy

- Pharmacist's license

- Good knowledge of regulatory requirements, particularly the EU GMP Guide

- Solid MS Office skills

- Strong organizational abilities

- Assertiveness and clear verbal and written communication skills

- Initiative and work reliably and meticulously

- Resilience, flexibility, and enjoyment of working in a team

- Excellent German language skills and good English language skills

What we offer:

- Competitive salary between 77,300€ and 93,800€ per year (full-time) plus a variable component

- Family-friendly benefits, including company daycare centers, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and more

- Access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, coaching, and mentoring programs

- Health awareness and opportunities for self-care through various measures, such as free health checks with the company doctor

- Inclusive work environment that welcomes, supports, and encourages you to bring your whole self to work

## Skills

### Required
- EU GMP Guide
- MS Office
- Pharmaceutical Affairs
- Quality Assurance
- Regulatory Requirements

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Source: [Apply at talent.bayer.com](https://talent.bayer.com/careers/job/562949977395231?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)