Quality Assurance Professional - Berlin, Deutschland - Syneos Health Clinical

Syneos Health Clinical

Geprüftes Unternehmen

Berlin, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Overview
Our customer is an innovative pharmaceutical company focused on covering unmet medical needs in the space of Dermatology.

This key role for the QA will involve ensuring that the distribution of our customer's products is done according to regulations in Germany, and that the company is compliant with local legislation and its Global procedures.

You will support the Global Quality organisation with oversight audits, inspections, projects, supply set up in Germany. You will become part of the Global Quality function for our customer, reporting into to the Quality Manager DACH.

Responsibilities

Act as quality assurance person and work closely with the "Stufenplanbeauftragter" in Germany as well the "Informationsbeauftragte" and the team
Work closely together with the affiliates within DACH (Germany, Austria and Switzerland).
Supports Quality Manager DACH and will work together with the regional team from Germany, Austria and Switzerland
Act as primary quality contact person with Third Party Logistics (3PL) provider, wholesalers, distributors/third parties in the markets for quality related requests
Decide on the final disposition of returned, rejected, recalled, or falsified products in collaboration with the Qualified Person at the manufacturing site and / or German customer service
Obtain and maintain new competencies and knowledge within relevant quality disciplines and industry trends
Make Out of stock notifications to competent authorities
Be responsible for updating/maintaining local Quality SOPs
Ensure compliance with appropriate SOP's, policies, and guidelines
Stop in closed collaboration with the global team and DACH Quality Manager the distribution of products if a serious/critical deviation happens
Responsible for the monitoring and management of quality/GDP related matters in the QMS.
Manage internal audits and external inspections from HA.
Willingness to travel when needed, not only to HQ but also to Austria or Switzerland and to visit the 3PLs, if required

Job Requirements

Degree in Pharmacy or in Life Science
Experience as Qualified Person (QP)
Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs
Experience with competent authority inspections and/or thirdparty audits
German and fluent English
Solid decisionmaking skills and computer skills
Other Skills
Strong verbal and written communication skills in English are essential
Ability to work independently and prioritize with mínimal daily instructions as well a positive attitude and problemsolving capabilities are important

Interviews may be conducted in person at an on-site interview location. For any in-person interviews, local Covid safety guidelines will be followed.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance.

We reward and recognise our people by providing valuable benefits and a quality of life balance.

About Syneos Health Syneos Health (Nasdaq:SYNH) is a fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs and commercial capabilities to address modern market realities.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialised. Here, each day brings an opportunity to take ownership of a new challenge. Teaming with some of the most talented clinicians in the industry, you'll improve patient outcomes and work in a dynamic environment to create better, smarter, faster ways to get biopharmaceutical therapies to patients. By joining Syneos Health, you'll be connected to our multitude of career paths and pipeline of employment opportunities.

WORK HERE MATTERS EVERYWHERE** | How will you accelerate improving patient outcomes?