Senior process technical understanding to ensure project execution at shopfloor level

• Support a culture of safety, quality, diversity, and inclusion.
• Can work with shopfloor technicians and provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV) and identify CAPAs to address any trends.
• Identify, assess, and own technical changes through GMP change control processes.
• Investigate deviations and determine root causes and identify CAPA.
• Act as Subject Matter Expert (SME) for the product and process knowledge and provide input to the Annual Product Review.
• Ensure processes are inspection ready at all times.
• Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.
• Support validation protocol generation and execution.
• Support on going self-learning and ensuring training is up to date.
• Provide guidance and support to production team through training and knowledge sharing.

• This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.
• This position may require shift work including weekends and off hours support.
• Strong interpersonal, written, communication skills along with problem solving and follow-up skills.
• Well organized, flexible and work with minimal supervision.
• Can work as a production shift lead to coordinate the on shift management.
• Be able to work as a production shift lead to coordinate the on shift management and other routine shopfloor team management.

Production support expertise when routine operations

• Monitor compliance activities necessary for the release of batches produced in compliance with the defined dates
• Ensure that the processes remain consistent with good manufacturing practices (cGMP) and apply the rules and regulations for safety, health and the environment.
• Provide a role of technical and scientific referent within his scope
• Ensure the appropriate management of the quality events within the appropriate timeframe (escalation, description, investigation of the cause, evaluation of the impact and criticality, etc.).
• Ensure the definition of corrective and preventive actions (CAPA) within the appropriate timeframe to effectively resolve the problem, reduce its impact and prevent its recurrence.
• Ensure the correct application of the change control processes
•  Ensure the consistency of decisions, with the right ratio of effort to benefit, correlation with the criticality of the events to be managed
• Provide methodological and organizational support for major investigations or problems. Lead the task force in the event of a crisis
• Ensure, in their area of expertise, that the strategic objectives related to the performance of the production unit are achieved
• Evaluate capacity, resource requirements together with Process Team Lead
• Oversee and support launch activities on the shop floor
• Support S&OP process with supplying necessary data
• Ensure the implementation of the on-call schedule, if applicable

Life cycle management and compliance activities

• Ensure the availability of appropriate operational expertise resources in order to maintain the validated state of the manufacturing processes in the unit as well as the qualified and validated state of the equipment in the area.
• Provide necessary support for the preparation and submission of regulatory dossier (in the context of transferring new products or variations of existing products / processes), and in answering questions from health and safety / environment authorities.
• Monitor the execution of regulatory commitments
• Manage risk analyses and gap assessment processes for the unit, and participate to the definition of Quality (SQRA, QP, etc.) and Safety (BCP, BBSP, etc.) road maps specific to the unit
• Manage the preparation, execution and follow-up of internal and external audits and GMP and HSE inspections
• regulations for safety, health and the environment
• Participate in the assessment of technical change requests related to the unit to ensure compliance with current GMP and HSE standards
• Represent the unit outside the site. Participate in expert working groups within Novartis

Batch administration

• Manage the production documentation flow within the production unit (SOPs; MBRs; Forms...)
• Responsible for the production part of the Batch record review activities (Production review, Experts review)
• Ensure that documentation is consistent with good manufacturing practices (cGMP)

HSE and Quality

• Guarantee the conformity of the manufacturing unit activities with regard to GMP and HSE rules, Novartis quality/safety policies, and the standards and quality/safety procedures
• Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site
• Ensure overall inspection readiness for area of responsibility.
• Guarantee the effectiveness of the Business Continuity Plan
• Be responsible for the implementation, compliance and governance of the practices explicitly defined in their role by the "Novartis Manufacturing Manual"
• Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management)

Operational excellence and continuous improvement

• Drive the Lean culture to achieve Process Excellence, including the daily use of Lean Leadership, Visual Management, Tiered Accountability, Leaders Standard Work and Gemba Walks
• Participate to the definition of the operational improvement strategy and the portfolio of continuous improvement projects. Plays a key role in the prioritization of improvement actions based on available resources
• Analyze all aspects of PU performance, identify and encourage continuous improvement through use of OpEx tools and methodologies, e.g. brainstorming, RCIs, debottlenecking studies and implementing best in class solutions
• Support Process Team Leads in Execution of identified improvement projects
• Project toll gate reviews including capture and validation of financials with BPA
• Promote proactivity Vs reactivity concerning the appearance and treatment of issues around the production process

Relevant Experience

• Minimum 8 years’ experience in pharmaceutical or life science industry in a GMP environment, preferably in commercial manufacturing
• Preferably minimum 3 year experience in an Expert role in GMP environment
• Experience in a team/people management role

Education & Qualification

• Bachelor degree in pharmacy, engineering, chemistry, biology, biotechnology or related (higher degree preferred) or completed vocational training with equivalent job experience
• Qualifications in Lean Management, Operational Excellence certificate or comparable advantageous

Laugnge：

• Proficiency in Chinese and advanced English in listening/speaking/reading/writing