Manager Visual Inspection/ Final Packaging

3 weken geleden

Almere, Flevoland, Nederland Sinclair Voltijd

The Manager Visual Inspection/Final Packaging (VI/FP) will ensure that daily and weekly demand planning targets are met. In addition, they will oversee weekly based VI/FP operations, addressing any necessary actions promptly. It is also crucial for the manager to regularly monitor the work floor and engage with Team Leads to review the daily routines, such as holding brief stand-up meetings or tier reviews. Improve the process of VI and FP.

Responsibilities:

* Ensure tasks are executed correctly

*Meet unit targets as per the demand plan

*Ensure smooth and compliant operations on the work floor

*Report any deviations or non-conformities to Planning immediately

*Promote and demonstrate both GMP and GDP awareness

*Maintain high performance standards and share knowledge with others

*Foster team spirit and address any issues within the team

*Be present during internal and external standards (e.g., DEKRA, NMPA, etc.)

*Ensure compliance with Quality Assurance standards.

*Responsible for managing the contract manufacturer.

*Backup to Production Manager Aseptic/Microspheres.

Main Tasks:

Process-Related Tasks:

*Oversee the production process, including batch documentation flow.

*Be fully trained in the processes and related activities responsible for.

*Initiate observations and non-conformities, guiding team leads through the process.

*Maintain equipment in a validated state, in cooperation with PT, ME, and Qualification Teams.

*Review and sign-off on important documents such as production related reports (QRs, EM Trends), NCs and CAPAs.

*Supervise projects in collaboration with other departments.

*Keep production overviews and documentation up-to-date.

*Perform ERP tasks in collaboration with the ERP specialist when necessary.

*Work closely with aseptic production manager and as a backup of each other.

People-Related Tasks:

*Manage people planning and adapt as needed in coordination with the Planning and Logistic Lead.

*Provide advice and support to team leads, senior operators, and operators.

*Ensure good communication between the work floor, Team Leads, Aseptic Manager, Planning and Logistic Lead, and Plant Manager.

*Conduct discussions with team leads, senior operators, and, when necessary, operators, including preparing reports.

*Serve as a role model for the entire OPS department.

*Be proactive, independent, and solution-oriented.

*Coordinate with HRBP to address operator-related issues.

Authorizations:

*Address operator performance & behaviour issues.

*Review batch records for completeness and accuracy.

*Revise document related to the production process.

*Oversee and participate in all process overviews

*Utilize ERP systems, making adjustment as necessary

*Manage and adjust people planning tools (e.g. Dyflexis)

*Collaborate in TEAMS, ensuring access to all relevant documents

*Provide coverage for the Planning and Logistic Lead as required

Role competencies:

*Ability to lead and motivate production teams to meet deadlines, forecasted targets and compliance standards

*Ability to effectively work with ERP systems

*In-depth understanding of ISO 13485:2016, GMP, GDP and other regulations

*Ability to communicate with cross-functional teams, auditors and management

*Ability to work under pressure and strong problem-solving skills

*Critical and Accurate

*Detailed and organized

*Quality minded

*Technical

Job Required Skills & Qualifications:

*Bachelor's degree (or equivalent) in a relevant field in Biomedical or Industrial Engineering or Pharmaceutical Sciences

*GMP & GDP experience

*3 years of experience in production management in the medical or pharmaceutical role

*Knowledge of process optimization & validation, equipment qualification

*Experience in working with a Quality Management System (QMS)

*Understanding of workplace safety and regulations

*Familiarity with environmental compliance, waste disposal and any sustainability initiatives.

Why Join Us:

Sinclair Pharma offers a unique opportunity to join a dynamic and rapidly growing organization at the forefront of injectable products and medical devices. As the Manager Visual Inspection/Final Packaging , you will play a key role. This is an exciting opportunity for an experienced Manager Visual Inspection/Final Packaging to make a significant impact while advancing in your career within an industry-leading company.

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