Quality Assurance Specialist

About the Role

Join PCI Pharma Services in Grossbeeren, Brandenburg, as a Quality Assurance Specialist dedicated to ensuring compliance with GMP guidelines, customer requirements, and site certifications. This role is positioned under a Senior Quality Assurance Specialist without personnel management responsibilities and focuses on maintaining quality assurance standards to deliver life-changing therapies globally.

Primary Responsibilities

• Manage and review quality events including deviations, nonconformances, complaints, and corrective and preventive action (CAPA) requests, and prepare their closing reports.
• Oversee change control processes by coordinating and following up with responsible stakeholders to guarantee timely completion.
• Facilitate cross-departmental communication and problem resolution guided by European GMP regulations.
• Develop, revise, and validate Standard Operating Procedures (SOPs), work instructions, and related documentation.
• Contribute to risk assessments and analyses within the quality framework.
• Support continuous improvement efforts and participate in validation and qualification activities as needed.
• Perform administrative tasks including maintaining logs, lists, folders, and compiling monthly quality system statistics.

Required Qualifications and Skills

• Completed vocational training with several years of relevant experience, or a Master's degree or equivalent in pharmaceutical, scientific, or technical disciplines.
• Proficiency in German and/or English, both spoken and written.
• Good command of MS Office applications including Excel, Word, and Outlook.
• Familiarity with GMP standards or related regulatory frameworks is advantageous.

Additional Information

PCI Pharma Services prioritizes equal employment opportunities and is committed to fostering an inclusive workplace environment encompassing fairness, respect, and equal chance for all individuals, regardless of demographics or background characteristics.