Quality Assurance Specialist at Hgli Nahrungsmittel GmbH

Germany, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

01 Jan, 27

Salary

50000.0

Posted On

03 Oct, 26

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Biotechnology

Description

The Kündig Group comprises internationally active production and trading companies and specializes in high-quality raw materials for the food industry. We are a dynamic and successful Swiss family business headquartered in Zurich. For our location in Ritschenhausen near Meiningen, we are seeking a [position title] to start immediately or by agreement.

Quality Assurance/ Quality Control Employee (m/f/d) GMP

To strengthen our quality management team, we are looking for a dedicated individual for a temporary parental leave cover position. You will work in a team of nine and, in line with your qualifications and experience, will take on tasks in quality assurance and quality control within a GMP-regulated environment. This involves close coordination with production, laboratories, suppliers, customers, and internal contacts.

Your tasks:

You support the organization and implementation of GMP-relevant tasks within your area of responsibility.
You maintain and further develop the pharmaceutical quality assurance system within the framework of applicable GMP requirements.
You process and track deviations, CAPA measures, and change requests in the change control system.
You review and approve quality-relevant documents, specifications, and manufacturing and testing instructions.
You will support qualification and validation activities in the laboratory and production areas.
You plan, conduct, and follow up on self-inspections as well as customer and supplier audits.
You qualify and monitor suppliers, service providers and external testing laboratories with GMP relevance.
You organize GMP training courses and monitor their completion.
You process and investigate quality-related complaints.
You will support product quality reviews and GMP-relevant communication with internal and external contacts.

Your profile:

You have completed vocational training or a degree in the field of food, pharmacy, biology or a comparable qualification.
You have professional experience in quality assurance or quality control, ideally in a GMP-regulated environment.
Knowledge of the food industry and/or experience in handling plant-based pharmaceutical ingredients is advantageous.
You have a good knowledge of the relevant legal bases, in particular AMG and AMWHV, as well as the relevant GMP requirements.
Experience with deviations, CAPA, change control, audits or supplier qualification is desirable.
You have good written and spoken English skills and are proficient in using common computer applications.
You work in a structured, careful and independent manner.
You communicate clearly, enjoy working in a team, and value collaboration in an interdisciplinary environment.
You are prepared to accompany internal and external audits and to participate in their preparation and follow-up.

Responsibilities

Quality Assurance/ Quality Control Employee (m/f/d) GMP

Your tasks:

You support the organization and implementation of GMP-relevant tasks within your area of responsibility.
You maintain and further develop the pharmaceutical quality assurance system within the framework of applicable GMP requirements.
You process and track deviations, CAPA measures, and change requests in the change control system.
You review and approve quality-relevant documents, specifications, and manufacturing and testing instructions.
You will support qualification and validation activities in the laboratory and production areas.
You plan, conduct, and follow up on self-inspections as well as customer and supplier audits.
You qualify and monitor suppliers, service providers and external testing laboratories with GMP relevance.
You organize GMP training courses and monitor their completion.
You process and investigate quality-related complaints.
You will support product quality reviews and GMP-relevant communication with internal and external contacts.

Your profile:

You have completed vocational training or a degree in the field of food, pharmacy, biology or a comparable qualification.
You have professional experience in quality assurance or quality control, ideally in a GMP-regulated environment.
Knowledge of the food industry and/or experience in handling plant-based pharmaceutical ingredients is advantageous.
You have a good knowledge of the relevant legal bases, in particular AMG and AMWHV, as well as the relevant GMP requirements.
Experience with deviations, CAPA, change control, audits or supplier qualification is desirable.
You have good written and spoken English skills and are proficient in using common computer applications.
You work in a structured, careful and independent manner.
You communicate clearly, enjoy working in a team, and value collaboration in an interdisciplinary environment.
You are prepared to accompany internal and external audits and to participate in their preparation and follow-up.