Deputy Head of Quality Control (m/f/d) – Pharmaceuticals

ROTOP Pharmaka GmbH; Dresden; Hybride; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

30 vacation days

Family leave 10 days

Modern workplace with height-adjust..

Parking & EV charging

Job-Rad

Jobticket

Team-building events

ROTOP Benefits Portal

Résumé du poste

ROTOP Pharmaka GmbH in Dresden is seeking a Deputy Head of Quality Control (m/f/d) for an initial two-year term. The role offers a modern workplace, flexible schedules, and strong focus on work-life balance.

The position features opportunities for professional growth within an internationally active company in a future-proof industry. You will oversee review of analytical reports, ensure GMP compliance with EU and FDA standards, and contribute to continuous improvement through audits and risk

Qualifications

• Professional experience in pharmaceutical quality control and in-depth knowledge of analytical methods.
• Good knowledge of current EU and FDA GMP requirements.
• Experience in evaluating analytical results and GMP-related documentation.
• Knowledge of handling out-of-specification (OOS) results, deviations, root cause analyses, and risk assessments.
• Initial technical or disciplinary leadership experience is a plus.
• Very good written and spoken German and good written and spoken English.

Responsabilités

• Review and evaluation of test reports for APIs, starting materials, and drug products.
• Ensure analytical compliance with pharmacopeia monographs and EU/FDA GMP requirements.
• Review and evaluation of GMP-related documents.
• Handle OOS results and deviations, including root causes and risk assessments.
• Evaluate stability studies and trend analyses; approve validations and verifications of analytical methods.
• Participate in supplier audits and audits of contract manufacturers.

Connaissances

Quality control expertise

Analytical methods knowledge

GMP knowledge (EU & FDA)

GMP documentation evaluation

OOS / deviations handling

Leadership experience

German and English communication

Description du poste

Your chance with us

Would you like to join an internationally active company in a future-proof industry?Due to our ongoing growth, we’re offering a position—initially for a two-year fixed term—in a modern work environment surrounded by nature (01328 Dresden). As Deputy Head of Quality Control (m/f/d), you can expect exciting responsibilities, flexible work schedules, and attractive benefits for an optimal work-life balance.

More than just a job

• A position initially limited to two years at a future-proof, internationally active company
• Flexible work schedules to help you best balance family and career
• 30 vacation days to recharge
• 10 paid days off when your child is sick to support your family
• A modern workplace (e.g., height-adjustable desks) surrounded by greenery
• Company parking and electric vehicle charging stations
• 3 days off at the company’s discretion
• Access to a diverse selection of attractive benefits through our ROTOP Benefits Portal
• Job-Rad and Jobticket for sustainable mobility
• Team-building company events to foster a strong sense of community
• Diverse career and development opportunities and additional benefits

Your tasks

• Review and evaluation of test reports for active pharmaceutical ingredients, starting materials, and drug products
• Ensuring analytical compliance with pharmacopeia monographs as well as EU and FDA GMP requirements
• Review and evaluation of GMP-related documents
• Handling of OOS results and deviations, including root cause analyses and risk assessments
• Evaluation of stability studies and trend analyses, as well as approval of validations and verifications of analytical test methods
• Participation in supplier audits and audits of contract manufacturers

Your profile

• Professional experience in pharmaceutical quality control and in-depth knowledge of analytical methods
• Good knowledge of current EU and FDA GMP requirements
• Experience in evaluating analytical results and GMP-related documentation
• Knowledge of handling out-of-specification (OOS) results, deviations, root cause analyses, and risk assessments
• Initial technical or disciplinary leadership experience is a plus
• Very good written and spoken German and good written and spoken English

Your team

Join our dedicated team and play an active role in shaping the future of our company.
If you’d like to contribute your skills in an innovative environment and further your personal development, we look forward to receiving your application.