We are seeking an experienced Quality Manager to ensure compliance and continuous improvement of Good Manufacturing Practice (GMP) standards across all production facilities.
Key Responsibilities
* Document Review and Approval: Conduct thorough reviews and approvals of analytical methods, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports to ensure compliance with GMP standards.
* Quality Agreements: Develop and maintain product-related quality agreements to ensure clear and consistent quality expectations and standards.
* GMP Support: Provide expert support to departments on GMP-related issues, offering guidance and solutions to ensure compliance and continuous improvement.
* Self-Inspections: Plan and execute self-inspections to identify areas for improvement and ensure adherence to GMP standards.
* Quality Oversight: Monitor and oversee the quality control processes for Synthetic Molecules Drug Substance and Drug Product operations, ensuring all activities meet regulatory requirements.
* Training and Development: Facilitate training sessions and workshops for staff to enhance their understanding of GMP requirements and quality standards.
* Risk Management: Identify and assess potential risks in production and packaging processes, implementing strategies to mitigate these risks.
* Continuous Improvement: Drive initiatives for continuous improvement in quality processes, leveraging data and feedback to enhance overall quality performance.
Requirements
* At least 5 years of experience in the pharmaceutical industry.
* Ideal professional experience in pharmaceutical development (Synthetic Molecules, Quality Control, or Quality Assurance).
* Knowledge of cGMP and quality requirements, ideally for clinical development phases.
* Good IT skills (MS Office) - especially experience with SAP and other quality management systems (e.g., Veeva).
* Excellent communication and teamwork skills.
* Independent working style, high quality awareness.
* Fluent in English, both written and spoken.