职位描述：
core activities /主要工作任务：
manage the performance qualification and requalification program for the ruide site.
manage the validation and stability activities for csl behring australia working within the site validation master plan and validation / stability sops to deliver optimal and compliant systems. optimal processes will be measureable, repeatable and compliant.
ensure equipment and processes have been installed adequately to allow validation and stability activities to be successfully undertaken. this will require the incumbent to be an active participant in installation, commissioning and qualification activities.
manage the extractable and leachable activities for csl behring australia.
manage the continued process verification activities for csl behring australia.
manage the product stability activities for csl behring australia.
manage and develop validation and stability master plans for csl behring australia.
manage the preparation, review, implementation and maintenance of departmental documentation for validation and stability activities (i.e. methods, standard operating procedures, protocols, reports, etc.).
qa role: approves validation and stability documentation as qa representative.
staff/人员管理任务
actively develop staff reporting into the process validation and stability group, both direct reports and subordinates, to ensure staff are competent to undertake the duties required within the process validation and stability group, in a safe manner.
ensure training requirements meet the needs of the roles, and training within the group remains current.
work collaboratively with all stakeholders, engineering, operations, r&d, qc staff and others, to ensure the validation and stability activities are planned and delivered in an efficient timeframe.
provide subject matter expert guidance and mentoring to site staff in validation and stability and the associated regulatory requirements.
build linkages between the process validation and stability group and csl behring sister sites to maximise the knowledge locally and sharing our findings with other sites.
lead by example and promote csl behring values in the process validation and stability department.
continuously develop team through training, further education, coaching and delegation of duties.
regulatory/监管性任务：
actively maintain current knowledge relating to qualification and validation activities with an emphasis in process validation, cleaning validation and stability. information will be gained from regulatory, industry and company sources.
promote the education and implementation of the relevant regulatory requirements including the nmpa code of good manufacturing practice, and other industry regulations and guidelines.
actively support regulatory inspections through ensuring currency of documentation, backroom support and/or direct presentations. ensure staff members reporting into the group are capable of delivering content the group is responsible for.
site goals /工作目标
provide leadership and direction to the group, ensuring performance is in line with the site’s core values, business plan and the csl ruide quality management system.
assist in budget preparation and forecasting. manage budgets allocated to the group, providing timely and accurate reports as required. ensure cost recovery is achieved where applicable.
position qualifications and work experience requirements/资质及工作经验要求：
a relevant science or engineering tertiary qualifications and demonstrated experience leading a technical team in a regulated environment experience ·
at least 5 years’experience in the pharmaceutical manufacturing industry with demonstrable experience in validation and/or stability. knowledge & attributes ·
strong knowledge of cgmp including current knowledge of industry guidance documents and standards focusing on validation principles and application relevant to validation and stability.
direct involvement with the regulatory aspects of the pharmaceutical industry through exposure to regulatory audits with particular emphasis to tga and fda regulatory environments.
demonstrated ability for conceptual and analytical thinking from a holistic system wide to detail view, with good judgement to reconcile ambiguities. competencies ·
able to lead staff by example, providing technical and personal support. able to work collaboratively with others to ensure successful outcomes.
excellent verbal and written communication skills with the ability to present to a range of audiences at all levels within the organisation.
excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.
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