Product Manager (m/w/d) Quality Control Compliance (befristet Auf 24 Monate)

Product Manager Quality Control Compliance

Halle, North Rhine-Westphalia, Germany

Simtra is a premier contract development and manufacturing organization that has been bringing sterile, injectable pharmaceuticals to market for over 65 years, with a focus on cancer therapeutics. With over 2,000 employees at our two locations in Bloomington, Indiana, USA, and Halle/Westfalen, Germany, we offer a broad portfolio of delivery systems, including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. In addition to GMP manufacturing, we provide additional services such as formulation and development support, lyophilization optimization, global regulatory support, and secondary packaging.

Simtra is formed by diverse teams in various fields! Become a part of the team and help provide life-changing medicines to patients worldwide.

We produce pharmaceuticals for the treatment of various cancers and other life-threatening diseases in our Halle/Westfalen plant.

For our team, we are looking for a Product Manager Quality Control Compliance (limited to 24 months).

In this position, you will ensure that the analyses of commercial contract products as well as active and raw materials in the quality control area are carried out according to pharmacopeial, regulatory, and customer requirements. Your responsibilities will include:

• Creation and optimization of test protocols, test methods, and specifications on which the basis of semi-finished products, active and auxiliary materials, and packaging materials are analyzed
• Evaluation and verification of compliance with cGMP guidelines in the analysis of products and starting materials
• Evaluation and resolution of analytical problems
• Processing of complaints, change controls, deviations, OOT/OOS events, and unusual findings
• Planning, supervision, and evaluation of ICH-compliant stability studies, compatibility studies, and special studies
• Supervision of all life-cycle management activities for approved products
• Creation of documents for cleaning validation
• Release of raw materials

You bring with you:

• University degree in pharmacy, chemistry, or biotechnology, ideally with a doctorate or a comparable qualification
• Professional experience in a GMP-regulated environment and in quality control is desirable
• Profound pharmaceutical, analytical, and regulatory knowledge (GMP)
• Ideally, skills and knowledge in the area of project management
• Organizational talent, problem-solving and assertiveness, as well as a sense of responsibility
• Very good IT skills (Word, Excel, Outlook)
• Very good German and English language skills in speech and writing

We offer you:

• Fair tariff-based remuneration including social benefits such as 13th month salary, holiday pay, company pension scheme, and additional nursing insurance
• In-house modern canteen with attractive subsidy
• 30 days of vacation plus special leave
• Weekly working hours of 37.5 hours
• Job-Rad leasing
• Corporate benefits: exclusive discounts for employees at numerous well-known brands
• Good transport links and free employee parking
• Professional relocation? We support financially within our relocation cost allowance
• Free company sports such as badminton, soccer, and fitness classes

We offer interesting opportunities in all phases of professional life to committed and talented people. Gender, age, skin color, origin, sexual orientation, and disabilities do not play a role - on the contrary: we promote diversity and believe that diversity is an enrichment.

We look forward to receiving your documents for your previous professional career directly via our online system.