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OBJECTIVES / PURPOSE
- Take ownership in the associated function as a Specialist
- Drive collaboration in the function to proactively solve problems and continuously improve processes
- Promote open culture to activate the teamwork
- Prepare Quality Agreement for MH (Marketing Holder) / vender in a timely manner.
- Conduct qualification process of new vender.
- Keep the qualified venders status up to date.
- Execute the required functional Quality Tasks to support KPI progress through performance dialogues
- Encourage team members and themselves to get them motivated and committed
- Develop and help talents be prepared for next functional lead position with multiple skills
- Proactively involved in the identification and implementation of continuous improvement opportunities (AGILE)
DIMENSIONS AND ASPECTS
Technical / Functional (Line) Expertise
- Primary knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines.
- Primary knowledge in API, solid dosage forms, parenteral technology, biologics or combination products.
- Primary analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
- Excellent verbal and written communication skills.
- Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
- Experience / expert with TrackWise Deviation / CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.
- Primary leadership skills and demonstrated success in managing a team.
- Primary interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, egender trust, influence key stakeholders, cooperate as a team lead, share information and deliver results with a team.
- Lead and involve members for bottom-up suggestions through open dialogues
Decision-making and Autonomy
- Primarily be able to deal with ambiguity, and make decisions under stressful conditions with manager’s support.
- Sense of urgency.
- Interacts with team members and relevant functions (Manufacturing, Engineering, Supply Chain, etc.)
- Interacts with global Quality functions.
- Share the best practices and expertise in / beyond the group
- Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
- Drive initiatives of “Quality Culture”, “AGILE 4.0”, “Digital” to drive continuous improvements.
- Improve and conduct functional processes within / across the functions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- High school diploma or higher diploma. Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline is preferred.
- Have knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
- Leadership and technical capabilities
- Business level of English skill is preferred (both verbal and written)