QA for DS/DP leader

Act as site QP to be responsible of manufacturing release of DS/DP/DAC and participant in GMP production activities, such as process transfer, validation etc. Work with functional department to create department SOPs and assure compliance with EU/FDA/NMPA GMP regulations. Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective Be responsible for setting up online DS/DP/DAC QA team in Fengxian site. S/he will work closely with manufacturing team, to support all GMP production activities. S/he will perform routine audit for manufacturing area, to assure GMP production in compliance with all regulatory, market, EU, FDA and company standards S/he will accountable to review and approve manufacturing generated documents, include but not limited: qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, QRM, etc.. S/he will ensure accurate reporting of MFG generated results and assure data integrity in daily activity. S/he will train his/her subordinate to meet the demand of company fast growth. S/he will be responsible for managing a team of employees across QA for DS/DP/DAC. S/he will be responsible in ensuring all associated performance management requirements are in place for each employee and relevant reviews are carried out regularly. In addition, s/he is responsible for relevant training is provided to employees who carry out DS/DP/DAC online duties to ensure site SOPs are followed, accurate identification of deviations or any other quality issues. S/he will liaise actively with cross functional teams when release DS/DP/DAC Other quality activities which supervisor assigned to

4. 04

   Requirements S/he must have strong QA experience It is desirable s/he has a knowledge of legislative, regulatory, market, biologics and data integrity requirements. Preferable that the individual has qualification Degree in vaccine and Biopharmaceutical Science It is advantegous if the individual has over 15 years working experience in vaccine/ bio-pharma or similar experience in a pharma/science background S/he must have strong communication skills with demonstrated ability to work in a matrix environment. Strong leadership competencies with demonstrated management 10+ years experience

5. 05

   Delegation of Responsibilities QA for DS/DP leader

. S/he will ensure all structures are in place to monitor, measure and ensure successful programme is applied. S/he will be responsible to ensure all necessary plans and standards are achieved consistently maintaining a high level of quality. 3.Essential Duties and