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Teamlead Quality Assurance Pharma (FvP) (f/m/d)

What you'll do
Teamlead Quality Assurance Pharma (FvP) facilitates the function teamlead for the SQP team as well as for the legal function of the responsible person (FvP – technical responsible person) of DNP Branch Site Sisseln. 

 We bring

• A team of diverse employees who aren’t afraid to think outside of the box 
• A truly global and collaborative team that cares about the experience of our employees 
• The encouragement you need to develop and achieve 
• A role that is highly visible and allows you to build your brand 
• A caring and supportive environment where you’re empowered to grow and share your ideas 
• A safe, inclusive workplace where you feel welcome

 

Your key responsibilities

SHE-requirements:

• Management of the process in full conformity with the DSM SHE requirements.
• Is exemplary with his or her own SHE-behavior and ensures the adherence of his/her employees.
• Intervene if watching unsafe acts or conditions.

Q-Requirements:

• Inspection, testing and evaluation of the entire manufacturing documentation.
• Checking and approval of quality-relevant deviation reports and "out of specification" (OOS) results in the context of the manufacture and testing of API.
• Inspection and approval of specification documents (manufacturing instructions, inspection specifications, etc.) as part of the manufacture, packaging and inspection of finished medicinal products by commissioned third-party companies.
• Approval of all approval-relevant change request inquiries (MoCs) in area of responsibility.
• Coordination and prompt implementation of product recalls in collaboration with Swissmedic.
• Timely reporting of quality reports in accordance with Swissmedic specifications.
• Testing, evaluation and approval of "Product Quality Reports" for medicinal products.
• Ensure that quality aspects with regard to the medicinal products distributed conform to the GxP EU legislation, local legislation, guidelines and other applicable regulatory standards.
• Ensure that medicinal products are stored and distributed appropriately in accordance with GxP.
• Ensure that manufacturers, clients and affiliates involved in trade of medicinal products hold a valid GxP license.
• Supporting in decisions for the selection and qualification of logistics / transport service providers and distributor centers.
• Support the warehouse HUB in disposition of returned goods, including the decision on reintroduction into saleable stock.

Interfaces:

• First contact person in the area of responsibility for department heads, in case the matter is related to one single department at the DSM Sisseln site.
• Communication with and information of headquarter functions in the area of responsibility.
• Responsible for coordination, organization and execution of customer audits, third party audits and regulatory inspections on the Sisseln site.

Resources:

• Resource planning to obtain the operative capacity to act (number of employees, training, exchange).
• Personnel management, development and manpower planning (appraisal interview, coaching, holidays and other absences).
• Goal-oriented leadership and motivation for the SQS-Team.

 

You bring

• Academic background, preferably PhD / master or equivalent education in pharmacy, life science, chemistry, biology or bio-chemistry.
• 5+ years experience in the pharmaceutical industry and / or production facilities, as plant manager or laboratory head or senior product QA Manager.
• Experience and expertise in quality management and quality assurance issues are required. 
• Solid and demonstrable knowledge of international GxP regulations / requirements and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment.
• Expert knowledge of technical manufacturing processes, analytical testing, logistical processes
• The individual must have the ability to independently solve problems and can work crossculturally.
• Advanced Leadership skills including: good communication and social skills/ability to work effectively in a team, presentation skills as well as reliability / autonomous working skills.
• Convincing leadership style to foster quality thinking on the site / BG
• The individual should be a person of integrity and be fluent in both German and English.
• Knowledge of chemical production processes and equipment.
• Relevant working experience in pharmaceutical industry as well as in a company with ISO certification.

 

How to apply 

Interested in this position? Please apply on-line by uploading your resume in English via our career portal [before {closing date}]. The procedure will generally be in line with the DSM application process outlined on the DSM career website. Due to privacy regulations we can only actively interact with applications via our career portal. 

* For further information, please contact Lamiaa Saif, Talent Acquisition Business Partner (Write an email). 

*Pre-employment screenings are part of the DSM Recruitment & Selection Process. You will be contacted when further information is required.

DSM Nutritional Products AG
Ms Lamiaa SAIF
.
Write an email