職位描述
職位描述：
Responsibilities:
1. Provide Quality Leadership within the cross functional Virtual Site Operating Teams.
2. Lead the development, implementation and support of QA/QC systems for Global as well as Local Pharmaceutical, Consumer and 3. Health Food & General Food products manufactured by our partners and contractors. Support new product launches and assists with the technology transfers.
4. Partner with the contractors and stakeholders to develop and negotiate quality agreements.
5. Drive the development, implementation and continuous improvement of Quality Systems to support current and future regulatory requirements.
6. Proactively support and provide for regulatory inspections and review/approval of responses to Regulatory Agencies as required
7. Provide Quality direction for significant deviations, significant complaints and change controls at contractor/partner sites that may impact quality, compliance status or require regulatory notifications.
8. Help provide inputs for preparation of Area Quality Review Team summaries and participate in relevant meetings.
9. Lead quality risk management activities and manage mitigation plans.
10. Apply technical expertise in cGMPs during audits of contractors and leadership of issue resolution.
Qualifications:
1. A degree in Pharmacy, Chemistry / Biochemistry/Pharmacy, Microbiology or other related science degree.
2. A minimum of ten years relevant post graduate experience within the pharmaceutical, Consumer and Health Food & General Food products industry.
3. At least four years of Product Quality Assurance experience in a GMP environment.
4. Strong computer skills, MS office knowledge and proficiency in English speaking skills are required. SAP and other enterprise platform knowledge is an advantage.
5. A proven ability to take on complex challenges and learn new tasks quickly.
6. Be an excellent team worker with demonstrated communication and influencing skills.
7. Demonstrated leadership, accountability, analytical capabilities and ability to resolve conflict.
8. Have the ability to effectively manage multiple projects, prioritize workload and accomplish tasks through effective team working.
9. In addition, the following proven experience within the China market is expected:
An in-depth knowledge of quality systems and China FDA regulations including a demonstrated ability to evaluate and apply global cGMP’s to build effective Manufacturing/QA/QC systems.
Experience in the manufacturing of solid oral dose pharmaceuticals, Consumer and Health Food & General Food products at Pfizer or another leading global pharmaceutical manufacturer.
