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Qc/Qa Specialist, Deputy Qp (M/W/D)
Posted on Nov. 14, 2025
- Berlin, Germany
- 0 - 0 USD (yearly)
- Full Time
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Vacancy Name
QC/QA Specialist, Deputy QP (m/w/d)
Vacancy No
VN253
Location Country
Germany
Location Region
Location City
Berlin
Employment Type
Full Time
Salary Range
Job Details
Are you an experienced Quality expert ready to join our team and help us shape the future of clinical trials in Berlin?
At Myonex GmbH we are looking for a dynamic QC/QA Specialist and Deputy Qualified Person (QP) (m/f/x).
About Myonex:
Myonex is a leader in providing integrated clinical and commercial services to support the advancement of life-saving medicine.
We partner with pharmaceutical, biotechs, and contract research organizations (CROs) in both clinical and commercial stages, including companies managing advanced therapies. With locations in the US, Germany, UK and France, Myonex supports projects globally.
Since 2022, Myonex Berlin is our Germany facility. With a long-standing experience in primary/secondary packaging and small batch-size IMP manufacturing capabilities, the Berlin facility brings expert and flexible support to early-stage clinical trials.
About the Role:
The QC/QA Specialist and Deputy Qualified Person (QP) supports Quality Control (QC) and Quality Assurance (QA) operations, ensuring compliance with GMP, GDP, and internal quality standards.
Note: This is an Office-based Role.
What you will do:
This role focuses on performing the following activities:
QC/QA tasks
Deputy QP tasks
- Perform and document Environmental Monitoring activities in classified areas.
- Maintain and update ERP master data related to QC and material management.
- Support facility, maintenance, and equipment qualification activities, ensuring compliance with GMP requirements.
- Conduct QC Goods Receipt, In-Process Control (IPC), and laboratory analyses of raw materials, intermediates, and finished products.
- Review Material Receipts and manage reference and retention samples, ensuring proper documentation and storage.
- Assist in product recalls and mock recalls.
- Participate in investigation and impact assessment of deviations with impact on GMP and/or product quality, as relevant.
- Participate in impact assessment and implementation of Change Controls and CAPAs with impact on GMP and/or product quality, as relevant.
- Manage assigned ERP Q tasks and contribute to system-based quality control processes.
- Assist with performing risk assessments (e.g. new activities, new or changes in current regulations…), as required.
- Assist in the preparation, review, and maintenance of Quality Technical Agreements (QTAs) with clients.
- Perform or assist in the performance of GMP / GDP audits of suppliers and associated follow up activities.
- Attend regulatory authority inspections and customer audits, as required.
- Participate or perform self-inspection activities covering the Quality Management System as determined in the self-inspection plan.
Deputy QP tasks
- Perform certification activities:
- GMP certifications of baches in accordance with AMWHV § 14 (Certificate of Conformance)
- Batch certifications according to AMWHV § 16 for the release of clinical trial materials and approved commercial products (Certificate of Batch Release)
- Import certifications of clinical trial materials according to AMG § 72
- Review manufacturing processes, records, quality control results, stability data and validation reports, to ensure that batches are manufactured in compliance with EU Good Manufacturing Practice (GMP) guidelines and national regulations (AMG, AMWHV).
- Perform documentation activities, such as:
- Maintain detailed and auditable records of batch certification activities in the release register
- Review and approve GMP related documents, including, but not restricted to Specifications, batch master records, customer and service provider QTAs, Product Specification Files.
- Maintain knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products which are certified.
- Participate in Quality Management Review meetings and in quality improvement initiatives specific to manufacturing processes and documentation.
- Participate in the developing and conducting GMP training to employees as required.
The Benefits:
- Competitive salary
- Bonus options, dependant on performance
- a full-time contract (40-hour-work-week)
- 29 days of paid vacation/year in addition to German public holidays
- pension scheme
- a friendly and helpful team culture
- office in Berlin-Charlottenburg with (limited) remote option
About the Candidate:
- A recognized university degree in a health-related or pharmaceutical discipline
- Recognition as a Qualified Person according to § 14 AMG and EU directive
- 3 years of experience in QC/QA areas with at least 1 year as QP
- Solid knowledge of ICH, GMP, GDP, GCP guidelines and relevant German and EU pharmaceutical regulations (AMG, AMWHV, EU 536/2014).
- Familiarity with ERP systems and digital documentation (e.g., SAP, Oracle, ZenQMS, TrackWise, or similar).
- Good understanding of equipment qualification and environmental monitoring processes.
- Strong analytical and problem-solving abilities, particularly for deviations, OOS, and CAPA investigations.
- Excellent communication and teamwork skills.
- High attention to detail with strong organizational and documentation accuracy.
- Fluent in both German and English
Most important of all, your values will align with ours: you will Be a Great Team Player, Be Client Focused and you will always strive to Learn & Grow and Find a Way. Join us at Myonex and contribute to our mission of delivering excellence in the clinical trials space.
We are a fast-growing organization with big ambitions… if this sounds like something you would like to be a part of, get in touch!
Myonex is committed to ensuring equal opportunity in all aspects of employment. We do not discriminate against anyone on the basis of race, religion/creed, color, gender identity, sexual orientation, marital status, pregnancy, national origin, ancestry, military status, disability or perceived disability, use of a guide or disability support animal, or membership in any other protected class as defined by applicable laws and regulations. If an employee or applicant feels they have not received equal or fair treatment, we encourage them to contact Human Resources.
To find out more about what Myonex do and who we are as an employer, head to our LinkedIn page and website.
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