職位描述
固體制劑化學(xué)藥生物藥新藥生產(chǎn)工藝固體制劑生產(chǎn)工藝
必須要有固體制劑相關(guān)工作經(jīng)驗(yàn), 了解固體制劑的生產(chǎn)工藝
Responsibilities:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, the position responsibilities include:
?Ensure quality and compliance in all actions:
oAttend GMP training on the schedule designated for role and as appropriate for role.
oAdhere to strict compliance with procedures applicable to role.
oExercise the highest level of integrity in the tasks performed.
oIn a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace.
oEmbrace a behavior of employee involvement and commitment to doing the job right the first time.
oEnsuring employees under the position’s scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
oPromoting an environment of employee engagement in the workplace.
oSeeking prompt identification, reporting and correction of deviations in the workplace as noted by employees.
?Execute technical projects in accordance with the HA and Kenvue policies and procedures
?Provide support to the in progress key projects which impacting revenue growth, quality improvements, compliance remediation, and cost reduction. Effectively collaborate with cross-functional team to optimize business results. Provide support to resolve issues impacting timely completion and achievement of project goals.
?Partners with the Validation CoE to execute site Process and Cleaning Validation activities
?Partners to deliver and execute key projects according to critical processes including, but not limited to, Tech Transfer, Characterization, Validation and EM site Hyper care.
?Support effective product lifecycle and knowledge management in close collaboration with the Regional and Global MS&T and technical need state leaders.
?Partner with Research and Development to establish and maintain processes for planning, developing, and commercializing new products resulting in well-characterized, validated, highly capable, cost effective manufacturing processes.
Education: Bachelor’s degree (or equivalent) in Chemistry, Pharmacy, or Engineering is required. M.S., or Ph.D in Chemistry, Pharmacy, or Engineering is preferred. Reference experience minimums noted below.
Experience: at least 5+ years of industry experience is required. Relevant experience includes product/process development of pharmaceutical/OTC /Medical Device products/NDNC product (adhoc.) , manufacturing of pharmaceutical/OTC/Medical Device products/NDNC product (adhoc.); R&D, Technical Services, Quality & Compliance, Validation experience or Engineering in pharmaceutical/OTC field.
Physical Demands: Office deskwork, requiring sitting, walking, using phone & computer. May lift up to 30 lbs occasionally.
Knowledge, Skills and Abilities:
?knowledge and application of NMPA, FDA, ICH and other applicable regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical and OTC products would be required
?Ability to collaborate with and influence internal and external manufacturing site leadership teams regarding prioritization and resourcing required.
?Ability to inform, communicate with, and influence Management regarding validated state of respective products/processes and indicated priorities required.
?Knowledge and application of pharmaceutical/OTC product and process development; life-cycle management of this class of products including strategies for continuous improvement would be desirable
?Knowledge and application of pharmaceutical/OTC manufacturing and formulation technologies for pharmaceutical and OTC products manufacturing and product development is desirable
?Exeprience in performaning process, cleaning or other validation activities in a regulated environment desirables
?Ability to provide technical support in problem-solving and decision-making; to collaborate with and influence business partner leaders with a focus on data, science, and technology required.
?Ability to constructively challenge cross-functional project teams and business partners to achieve project goals and global make strategic plans required.
?Collaboration, communication, and presentation skills required.
?Fluent knowledge of Chinese and English is required.
?Flexible to travel is required.