Quality Assurance Manager Qc
vor 6 Monaten
**About** the **role**:
An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 670 employees) for a Quality Manager, within the Quality Assurance Department.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Unit team within a world-class Biotech manufacturing environment.
The scope of the role is to manage the day-to-day and the medium to long-term operations related to Quality Control and Raw Material activities related to sterile biologic products manufacturing, ensuring compliance with the license, regulations as well as cGMP Regulations. He/she will manage and develop his/her team to contribute to their career growth. The job holder is expected to act as Qualified Person Delegate.
**How **you** **will** **contribute**:
- Ensures the day-to-day quality oversight of the Quality Control activities and Raw Material management related to his/her scope of responsibility
- Ensures raw material release and manages specifications
- Collaborates with suppliers to address quality issues and implement corrective action plans
- Responsible for the effective management of the quality systems operating in his/her scope, including deviations (events), CAPA, batch review, change control, documentation, etc. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance.
- Supports the Quality on the Shop Floor culture
- Provides direction in the event of manufacturing incidents that may potentially affect quality or compliance
- Ensures that deviations and complaints are investigated, reports are available
- Ensures that escalation mechanisms as defined in site regulations are being adhered to
- Supervises ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas in the successful performance of these activities.
- Ensures a constant alignment with his/her QA peers to provide a consistent quality support to the entire Neuchâtel site and beyond
- Cultivates a smooth and collaborative partnership with his/her local and global business partners (i.e., Laboratories, Supply Chain, Manufacturing)
- Contributes to site strategic projects and objectives
- Contributes that responses to Regulatory and Compliance requests (RA questions and submissions, Observations, Compliance gaps, Audits, etc.) related to his/her group are provided in a timely manner and with appropriate level of quality
- Represents area of responsibility internally and externally
- Acts as QP delegate and perform all related activities including batch disposition
- Manages a team of about 10 people and conduct Compensation reviews, Performance Review Conversations, Setting of Objectives, Development Plans
- Manages the resources to ensure medium to long-term partmental objectives and time scales are achieved
- Owns personal accountability for all EHS Aspects, ensuring his/her team is operating in a safe workplace
- Drives continuous improvement and Lean Culture
**What you bring to Takeda**:
- University degree in Life Science
- Minimum 5-10 years of experience in sterile and/or biological products pharmaceutical industry with extensive experience in Quality Control operations
- At least 5 years of experience in people management
- Good knowledges of method validation/verification and equipment/software validation requirements
- Excellent knowledge of cGMP/GLP
- Experience of aseptic filling under isolator and of visual inspection is highly appreciated
- Qualified Person/delegate experience is a plus
- Fluent English (C1) and French (min B2) is a must
**What Takeda offers **you**:
- Competitive salaries
- Full accident coverage
- Participation in health insurance premiums
- Advantageous pension plans
- Subsidised meals
- Financial participation in employee sports activities
- Transport: support for local public transport passes, free parking, car sharing programme.
- Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies
- Takeda Neuchâtel is an employer committed to its employees and to future generations.
**Learn more about Takeda **Neuchâtel**:
- With more than twenty nationalities, Takeda Neuchâtel offers an international, _diverse_ and innovative working environment within a company that is firmly rooted and committed to its local ecosystem._
- Takeda Neuchâtel is certified as a training company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, _logistics_, _IT_ and biopharmaceutical production._
- "Empowering our people to shine:_
- Takeda is proud of its commitment to creating a diverse
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