GXP Quality Assurance Senior Specialist

Job Description Overview

As a GXP Quality Assurance Senior Specialist, you will be responsible for conducting audits, managing quality systems, and collaborating with cross-functional teams to uphold and enhance GXP compliance. The Senior Specialist will play a crucial role in maintaining and improving the organization's quality management systems. You will collaborate with development, testing, and operations teams to streamline workflows and enhance efficiency across the entire software development lifecycle.

Responsibilities

• Provide direction, guide, and coach a team of QA professionals to provide quality oversight over GMP operational activities and product release to ensure compliance with cGMP and defined quality requirements.
• Lead Operations to ensure inspection readiness at all times.
• Manage release of product batches, including owning the QA product release workflow in M42 products.
• Develop SOPs.
• Develop IQ, OQ, QMS processes.
• Perform CSV tasks.
• Develop change management process.
• Train other team members on GXP.

Qualifications

• University degree in relevant Science or Engineering discipline.
• A minimum of 10 years experience in the pharmaceutical industry.
• Demonstrated experience with helping operations to Develop for FDA and EMA GMP inspection.
• In-depth understanding of cGMP regulatory and regulatory requirements of the pharmaceutical industry.
• Strong experience Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes.
• Ability to apply optimal quality assurance standards to promote a business edge.
• Ability to facilitate business activities compatible to the international regulatory environment.
• Ability to communicate effectively within the site organization and across the network.
• Good people management skills.
• Good risk management skills.
• Good Audit handling Skills.
• Good document writing skills.