Contract QA Validation Senior Specialist (f/m/d)

The incumbent in this role will offer support in ensuring regulatory compliance throughout the entirety of the product lifecycle, specifically focusing on validation activities related to equipment qualification, Computerized System Validation (CSV), and Cleaning Validation. They will provide guidance documents to ensure alignment with relevant industry standards and requirements. Key responsibilities include:

Tasks include:

1. Participating as the Quality Validation representative for site projects involving the implementation of new manufacturing equipment, facilities, utilities, and cleaning validation programs.
2. Reviewing and approving qualification and validation documentation, including risk assessments, protocols, and reports.
3. Evaluating, reviewing, and approving deviations, discrepancies, and changes controls that arise during equipment/system qualification/validation within their area of responsibility.
4. Providing support for Data Integrity assessments for new equipment/systems. e. Reviewing and approving procedures associated with project deployment.
5. Additionally, as needed, the role will provide Quality Assurance (QA) support to Subject Matter Experts (SMEs) to ensure adherence to procedures and industry standards.

Requirements for the role include:

1. A strong understanding of manufacturing and packaging processes for solid oral dosage forms, as well as Quality Control (QC) processes.
2. Experience with Change Control, Deviation Management, and Risk Management Quality Systems.
3. Proficiency in equipment qualification, Cleaning Validation, and CSV, including an understanding of automation elements.
4. Familiarity with common office software such as Microsoft Office Word, Excel, and PowerPoint.
5. Experience in change management during project implementation, as well as handling protocol deviations and discrepancies.
6. Proficiency in employing a risk-based approach to qualification/validation.
7. Experience in Data Integrity.
8. A solid understanding of the drug development process from discovery through regulatory filing and approval of drug applications, as well as commercial manufacturing processes.