Team Lead QA Compliance (m/f/d)

Be part of a vital chain and contribute to our common goal of improving the lives of people. Octapharma is one of the world's largest manufacturers of drugs based on human proteins and develops and produces drugs from human plasma and human cell lines. We are a privately run company where the warmth of a family atmosphere meets the strength of a global organization.

The Octapharma production company Deutschland mbH (OPGD) in Springe near Hannover is one of five state-of-the-art production sites. There we produce with our around 850 employees: a finished product and intermediate products for further processing.

In your role as Team Lead QA Compliance (m/w/d), you lead your working group and are responsible for ensuring compliance with the quality systems of the company. This position is sought in full time with 38.5 hours per week and indefinitely. Design our vision to create new health solutions that improve people's lives.

Monitoring all functions related to the following quality systems: change control, self-inspection, qualification of suppliers and service providers, product complaint, product quality reviews (PQRs), qualification/validation Instruction, training and leadership of employees and implementation of the group's budget and resource planning Provision of SOPs for testing and approval for qualification, internal audits, supplier qualification, product complaints, PQRs and documents Provide guidance on GMP and quality systems for site personnel Creation, testing and revision of SOPs for the various quality systems Local and cross-site interface to QS departments of other locations and group functions Implementation of supplier audits Key stakeholders for audit and inspection activities with responsibility for the preparation and management of the back office in audits and inspections

Completed pharmaceutical studies or natural science training and additional training Mind. 3 years of professional experience in the GMP-regulated area Experience with internal audit processes / EU & FDA regulations (including 21 CFR 210 & 211); certified auditor Knowledge of principles & methods of quality management and relevant standards & laws (GMP, AMG, AMWHV) Secure IT user knowledge (in particular MS Office) Very good German and English knowledge in Word & Writing Leadership and enforcement and persuasiveness Teamability, reliability and good organizational skills Precise, careful, independent & structured work Your department where you do something The area of quality carries the overall responsibility for the quality control and safety of our medicines with the aim of ensuring the safety of our patients. The area is divided into four departments: Quality Assurance, Quality in Operation, Quality Control and Assessment & Release. The Quality Assurance is responsible for document management, coordination of GMP training, change management and supplier qualification and auditing with around 25 employees.

You help to save lives - every day is important, because we make life-saving drugs Social benefits - employer-funded occupational pensions, long-term account, Hansefit, Benefit portal with advantageous offers, bicycle leasing, external health coaching and regular company celebrations Expertise development – We offer various internal and external employee and executive training, trainee programs and digital solutions Miscellaneous - With us you can start the short Friday earlier in the weekend