Job Summary Be responsible for the manufacturing management and team management of the inspection((VI&AVI)) area to ensure the stability and compliance during the production. Timely solve the problems occurred in the production process. Participate in the audit as SME of the inspection area. Be responsible for the implementation, tracking and closed-loop of quality events such as CAPA change and deviation in the inspection area.
Key Responsibilities · Be responsible for DP Inspection team management including · Coach team members to establish personal development plan & annual performance goals, and provide continuous tracking and feedback. Pay attention to personal development needs and establish a good team atmosphere · Identify high-potential employees, develop SME and shift leaders，establish flexible shift system; · Be responsible for the maintenance of team organizational structure and personnel recruitment, ensure that the personnel development is in line with the post needs, and improve the enthusiasm of personnel · Be responsible for DP Inspection during the manufacturing phase including but not limited: · Be responsible for the production plan and personnel arrangement in the Inspection area, organize and coordinate personnel to complete the pre-production preparation, production and post-production clearance. · Identify the abnormalities in the production process, solve the problems at the front line of production and ensure the successful delivery of production. · Focus on the feedback on production problems, develop the direction in combination with the regulations and industry guidelines and improve the quality of production delivery · Focus on the differences between on-site implementation and document provisions, and continuously improve the personnel operation awareness and compliance in combination with the audit and regulations · Establish and continuously optimize the post standard workflow, and organize team personnel to pass the operation certification · Ensure safe operation of work areas, identify and eliminate safety hazards, and provide ongoing safety education and oversight of team members · Be responsible for C&Q phase of the process equipment as the end user role including but not limited: · Working with QV and vendor team during C&Q phase · Draft GMP documents such as URS etc. according to the SOP · Leading as needed during the FAT, SAT phase · Regulatory inspection and client audit: · Audit related work: support the notification and preparation of audit activities related to DP department; Cooperate with the organization and coordination of audit findings; Cooperate with other audit related tasks，suck as audit preparation meeting organization，audit related issue tracking; · SME of the Inspection. · Document and compliance management · Be responsible for the document management, organizing and coordinating personnel to complete the acquisition of blank controlled paper, application, arrangement and archiving of forms/notebooks · Organize the coordination team to complete the SOP drafting and optimization. Ensure that the content of the document closely follows regulatory and industry guidelines and is continually improved as appropriate. · Deviation /change control/ CAPA/ risk assessment related activity：change control drafting and implementation, deviation Investigation, risk assessment drafting; Follow up deviation status, and ensure the compliance with deviation procedure; Arrange the investigation discussion, update the progress and collect the feedback · Other works arranged by the line manager. Qualification · College degree or above, major in pharmaceutical related subject · Good English in read and write, good English speaking is a plus Experience · +5 years’ related experience in pharmaceutical company · Experience in other DP function is a plus Other Skills, Abilities and experience:
· Knowledge of FDA, EU, WHO, NMPA GMP related requirements · Be familiar with Microsoft office software for document handling such as Word, Excel, Power point, Visio etc · Have the ability to use tools such as PSP to analyse and solve problems · Pro-active, high sense of responsibility, self-discipline · Production-oriented comprehensive working system, can respond at any time · Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability
