AstraZeneca Pharmaceuticals LP Senior Compliance QA Engineer in Wuxi, China

-Provide coordination and oversight of functional quality & compliance

-Partnering in IMTs

-Encourage function ownership of Quality

-Sustain standard process for each PQS across site

-Conduct Regulations and AZ global QCM compliance Evaluation

-Agree PQS/GMP improvement priorities

-Lead regulatory inspection preparations

-Lead and coordinate Quality key systems in place and improvement, including, but not limited,

-GMP training

-Document management

-QAA management

-CAPA address, feedback and follow up

-Change control

-Quality risk management

-Self-inspection

-KPI data collection andreporting to global

-Quality performance review and reporting

-Continuous improving on quality and compliance

-Coordinate and lead GMP inspection from external heath authorities

-Coordinate the communication with local healthy authority

-Coordinate Site registration in China market.

-Support CMCRC for site registration and product registration in global markets.

-Support China RA for product registration in China market.

-Support China Tendering team for entrusted inspection in China market.

-Provide support and administration on QA E-system, eg. SAP, AZDoc, OCM, IDM etc.

-Provide Coaching for peer and team member to handle QA affairs

-Compliance with AZ code of conduct and SHE requirement

Requirements:

-University graduate, major in pharmaceutical or related subjects

-5 years plus experience as quality assurance

-Good GMP and quality system management knowledge

-Knowledge of process control methodology and statistics, for example Cpk, FMEA

-Knowledge of product process and typical equipment

-Working knowledge of Microsoft applications, SAP or similar system

-Good English

-Good Computer skill

-Good communication skills, proactive leadership, strong quality minds and strong service minds