Work Schedule
Rotational days/weekends
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Purpose of the position/responsibilities:
The Team Leader, Sterile 7, will play a pivotal role in ensuring the achievement of quantity and quality objectives for production activities within our department. You will plan, supervise, and control these activities, adhering to company procedures, quality standards, safety regulations, and environmental guidelines. Your leadership will be essential in driving our team to success and maintaining our world-class standards.
In this role you will work closely with other internal functions, such as with Planning, Quality, Maintenance, and Engineering teams, and interact with customers and suppliers to ensure seamless operations.
Specific tasks/primary activities:
Production Planning
* Ensure flawless production planning within weekly and daily timeframes.
* Assign tasks to operators, adhering strictly to budget and planning instructions.
Production
* Coordinate compliance with production quantities, times, and quality.
* Supervise the department's production activities, ensuring all documentation aligns with GMP and customer requirements.
Quality
* Aid the Department Supervisor in tracking the application of SOPs.
* Complete planned validations and ensure production data aligns with GMP before submission to Quality.
Employee Management
* Direct, coordinate, and control the team to achieve high performance and motivation.
* Analyze training and development needs to improve team results.
Procedures
* Draft and continuously update SOPs and operational procedures.
* Periodically verify and update procedures in compliance with GMP requirements.
Consumables
* Manage stock levels and order necessary consumables for production.
* Ensure compliance with the assigned budget.
Cost Control
* Support the Supervisor in tracking and managing costs.
* Account for activities and load products into the computer system in line with budget constraints.
Maintenance
* Coordinate maintenance activities to ensure equipment efficiency.
* Report anomalies and support actions to resolve production issues.
Sampling
* Ensure accurate performance of chemical and microbiological sampling activities.
* Compile related documentation as per current SOPs.
Requirements and qualifications:
Studies/Diploma/Training courses:
* Degree or equivalent experience in CTF, Chemistry, Chemical Engineering, or a related field.
* Alternatively, a relevant diploma with experience in the pharmaceutical sector.
Technical and IT knowledge:
* Proficiency in main software applications.
Professional experiences:
* Proven experience in drug production or personnel management/coordination.
Languages:
* Proficient in English.
Personality traits:
* Strong leadership skills.
* Outstanding group management abilities.
* High sense of responsibility and availability.