Quality Assurance Manager - Pharma (m/w/d) at ADENI Recruitment Agency

berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

23 Dec, 26

Salary

60000.0

Posted On

24 Sep, 26

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

our tasks:

As Quality Assurance Manager at this international company, you will take on diverse tasks for the quality and compliance of business activities in Germany and Great Britain and will be responsible for, among other things, the following activities:

Responsibility for the quality management system (QMS) as well as its maintenance, further development and continuous improvement, taking into account GMP, GDP and applicable regulatory requirements.
Ensuring proper maintenance and control of SOPs and other quality-relevant documents
Internal teams and commissioned external partners verify compliance with quality requirements and existing procedures.
Planning and execution of internal audits as well as support for external audits, regulatory inspections and supplier qualification
Handling product quality complaints and quality-related inquiries, as well as coordination with the respective contact persons.
Support and close collaboration with Regulatory Affairs and Pharmacovigilance
Collaboration with internal and external partners as well as participation in other cross-departmental projects and tasks

Your profile:

They work systematically, approach their tasks in a solution-oriented manner, and take responsibility independently; furthermore, they possess the following qualities:

Completed studies in pharmacy, chemistry, biology or a comparable natural science degree program
Excellent or fluent German and English skills.
Three years of professional experience in the pharmaceutical quality assurance environment is highly advantageous.
Knowledge of EU GMP guidelines and GDP requirements is highly advantageous.
Additional knowledge or professional experience in Regulatory Affairs and/or Pharmacovigilance is highly desirable.
Knowledge or experience in the field of orphan drugs is highly advantageous.
Good knowledge of MS Office.

Responsibilities

our tasks:

Responsibility for the quality management system (QMS) as well as its maintenance, further development and continuous improvement, taking into account GMP, GDP and applicable regulatory requirements.
Ensuring proper maintenance and control of SOPs and other quality-relevant documents
Internal teams and commissioned external partners verify compliance with quality requirements and existing procedures.
Planning and execution of internal audits as well as support for external audits, regulatory inspections and supplier qualification
Handling product quality complaints and quality-related inquiries, as well as coordination with the respective contact persons.
Support and close collaboration with Regulatory Affairs and Pharmacovigilance
Collaboration with internal and external partners as well as participation in other cross-departmental projects and tasks

Your profile:

They work systematically, approach their tasks in a solution-oriented manner, and take responsibility independently; furthermore, they possess the following qualities:

Completed studies in pharmacy, chemistry, biology or a comparable natural science degree program
Excellent or fluent German and English skills.
Three years of professional experience in the pharmaceutical quality assurance environment is highly advantageous.
Knowledge of EU GMP guidelines and GDP requirements is highly advantageous.
Additional knowledge or professional experience in Regulatory Affairs and/or Pharmacovigilance is highly desirable.
Knowledge or experience in the field of orphan drugs is highly advantageous.
Good knowledge of MS Office.