Compliance Specialist (m/f/d)

Are you a Compliance Clerk and already have some experience in quality control? Are you looking for a new and varied role in which not only your specialist knowledge but also your ability to work in a team and motivation are valued?

Then our team of experts at Randstad professional solutions has the right position for you : We are currently looking for an Employee Quality & Compliance at the Penzberg site on behalf of our business partner in the pharmaceutical industry .

Apply today and start your new job tomorrow! We do not exclude anyone, but welcome every application.

Here's what we offer

• Attractive salary package with Christmas and vacation bonuses
• Reimbursement of travel expenses
• Up to 30 days vacation per year
• Further training through e.Learning offers
• Open corporate culture

Your tasks

• Supporting the Group Manager and other managers on issues relating to Quality & Compliance
• Preparation of the internal batch record review in consultation with the responsible product group manager
• Preparation of the risk-based evaluation of the batches produced and coordination of the root cause analysis and action tracking in the event of deviations with the involvement of all relevant interface partners
• Maintaining the internal release system (SAP-based) for the digital storage of all batches produced
• Independent creation of deviation reports in collaboration with the relevant interface partners
• Coordination, processing and updating of internal manufacturing regulations in collaboration with all relevant interface partners
• Creation of SOPs and specification documents
• If necessary, training employees in compliance with the applicable quality management system
• Ensuring the correct filing / archiving of records and documents in accordance with the currently valid specifications
• Independently creating and maintaining change requests (equipment) in the area and independently coordinating all necessary actions in accordance with the applicable specifications
• Accompanying tours of the production areas
• Checking hygiene measures (hygiene plans) and following up on actions resulting from monitoring limits being exceeded

Your profile

• Degree in natural sciences (preferably a Master's degree in chemistry)
• Ideally professional experience in the pharmaceutical or chemical industry
• Experience in or understanding of production and quality control processes and general business practices within the regulated diagnostic / pharmaceutical industry
• Knowledge of the relevant DIN ISO standards (13485, 9001) and other relevant regulations (e.g. GMP, IVDD, FDA QSReg)
• Experience in process analysis, qualification and validation
• Fluent German and good written and spoken English skills
Vor 30+ Tagen