A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
This position will establish and maintain QMS, and manage documentation for GMP site of E2E APAC during construction phase and operation phase. The primary responsibility of this position is to ensure the continuous improvement of quality on site.
Internally, this position will work with all GMP operation teams and other quality team members of E2E APAC. Externally of E2E APAC, the (senior) QA specialist will work with other necessary teams including but not limited to regulatory, quality teams of other functions and overseas global quality teams of company.
QDS establishment and maintain for GMP site
• Draft and establish quality relevant SOPs;
• Review and approve SOPs drafted by other GMP operation teams;
• As SLU to assign and maintain ManGo accounts for GMP teams.
• Upload, distribute, maintain and archive all kinds of quality documents.
Establish and maintain training system
• Lead overall training management of GMP site;
• Identify training needs, establish and implement training plan for GMP site;
• Establish personal training matrix and file for quality team;
• Assist other GMP operation teams in establishing personal training matrix and file;
Compliance and continuous improvement
• Implement quality system in a risk-based manner;
• Organize self-inspection and follow up CAPA;
• On site management of GMP site from QA perspective to assure continuous improvement;
• Perform Routine review based on KPIs and KQIs.
Overall management of deviation & CAPA, and change control
• Participate in investigations and follow up;
• Coordinate necessary resources to guarantee plans are followed.
Act as counterpart for DSP production team for all its quality relevant activities.
Responsible of material and consumable release.
Lead and act as the Subject Matter Expert of quality for routine quality operation, internal/external audits, health authority inspection and client communication.
Accomplish other tasks assigned by line manager.
Respect and follow EHS rules.
Who you are:
• Bachelor degree or above
• Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds
• Minimum 3 years working experiences in GMP environment;
• Solid knowledge of cGMP, FDA, EMEA, and other quality regulations;
• Rich experience of pharmaceutical operation and on-site management;
• Ability to follow written procedures, SOPs, specifications and other documents;
• Familiar with bio-pharmaceutical production process.
• Pharmaceutical production experience;
• Experience of material, intermediate, or product release;
• Good organization and communication skills;
• Demonstrated leadership;
• Able to handle different tasks at the same time.
• Fluent English speaking, reading and writing
• Good technical writing skills in English is a plus
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com