Zentiva

Produces branded generic pharmaceuticals in Europe

GMP Auditor

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

University education in pharmacy, chemistry, pharmaceutical technology, biology, or a similar field.
English proficiency in speaking and writing; Czech is not mandatory.
Microsoft Office skills, including Excel, Word, and Outlook.
Experience in the pharmaceutical industry or quality is required.
At least two years of experience as a GMP or GDP auditor.
Ability to travel worldwide, especially in Europe and Asia, up to 70% of working time.
An active category B driving license.

Responsibilities

Act as a qualified GxP auditor according to the internal and third-party audit plan.
Negotiate audit dates with auditees.
Prepare audit data.
Manage audit trips.
Conduct audits.
Write audit reports and request corrective and preventive action (CAPA) proposals.
Review and confirm CAPA proposals.
Follow up on CAPA when needed.
Manage audit documents in TrackWise and other systems.
Review audit reports produced by external companies and manage them in TrackWise.
Participate in training and self-training.
Help establish the auditor training process and participate as a lecturer.
Prepare and justify regular reporting in the respective area.
Perform other tasks assigned by the manager within the agreed type of work.
Follow the line manager’s requirements and the job description.
Follow tasks and timelines established for activities and projects.
Work independently and proactively.

Desired Qualifications

Knowledge of an additional language.
Experience with TrackWise.
Certification as a GMP auditor, such as ECA or IRCA.

Are you an experienced GMP/GDP Auditor looking for a role where you can combine your quality expertise with international travel and real influence?

Join Zentiva as a Quality Systems Auditor and become our trusted expert assessing the quality systems of manufacturing partners, suppliers, and service providers across Europe and Asia. You'll conduct independent GxP audits, drive continuous quality improvement, collaborate with global stakeholders, and help ensure patients receive high-quality medicines.

If you're passionate about pharmaceutical quality, enjoy working independently, and are ready to travel internationally while making a tangible impact, we'd love to hear from you.

MAIN ACCOUNTABILITIES AND DUTIES

To act as qualified GxP auditor based on the Zentiva internal and third party audit plan.
- To negotiate the audit date with auditee
- To prepare data for the audit
- To manage the audit trip
- To carry out the audit
- To write the audit report and ask for CAPA proposal
- To check and confirm the CAPA proposal
- To follow up CAPA if needed
- To manage all audit documents in TrackWise and other systems
To review the audit reports done by the external companies and manage them in TrackWise.
To participate in trainings/self-trainings.
To help set up the Zentiva auditor training process and participate as the lector.
To prepare and justify regular reporting in respective area.
The employee will perform other tasks under the direction of the Manager within the agreed type of work.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

University education (pharmacy, chemistry, pharma technology, biology etc.)
English language in writing and speaking, other language is the advantage (Czech is not mandatory)
Microsoft Office – Excel, Word, Outlook
Experience in pharma industry or quality lag is a must
Experience as the GMP / GDP auditor at least two years
Experience with TrackWise is the advantage
Ability to learn / quick adaptability / analytical / organized / communicative
To follow requirements of solid line manager and job description.
To follow tasks and timelines, set for particular activities and projects.
To work independently, to be proactive.
Ability to travel worldwide esp. Europe and Asia (up to 70% of working time)
Certification as GMP auditor (ECA, IRCA …) is an advantage
Driving license B – active driver

About the Company

Zentiva

Produces branded generic pharmaceuticals in Europe

Zentiva makes branded generic medicines for European markets. Its products are off-patent drugs reformulated and marketed under Zentiva’s brands, delivering the same active ingredients and dosage as original medicines at lower prices. It differentiates itself through a long history as an independent platform under private equity, with a growth strategy built on acquiring brands to expand its European footprint. The goal is to become a leading European branded generics platform and improve access to affordable medicines across its markets.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Prague, Czechia
Founded: 2003

Recently Posted Jobs

Explore more opportunities at Zentiva

See more jobs