Lead Sterile Area, St.7

Work Schedule

Rotational shift nights/weekends

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Purpose of the Position/Responsibilities:

Lead needed at Thermo Fisher Scientific Inc. to manage production goals in Sterile Area.

Specific Tasks/Primary Activities:

Production Planning

• Successfully implement detailed production plans by assigning tasks to operators in accordance with budget and planning instructions.

Production

• Coordinate world-class standards in production quantities, timing, and quality through effective direction, coordination, and control. Lead all aspects of batch records and department documentation to guarantee compliance with all requirements.

Quality

• Collaborate with the Department Supervisor to monitor SOP application, ensure compliance with master batch record instructions, and verify in-process controls. Validate production data aligns with GMP and company policies.

Procedures

• Continuously update SOPs and operational procedures, ensuring they meet current GMP requirements and align with Supervisor instructions.

Consumables

• Manage the inventory levels of the department by ordering necessary consumables, ensuring compliance with the assigned budget.

Cost Control

• Assist the Supervisor in controlling costs by accounting for activities and loading products into the IT system, adhering to budgetary constraints.

Maintenance

• Coordinate maintenance activities with Technical Services, ensuring production plant efficiency and timely anomaly reporting. Support problem-solving for production issues.

Sampling

• Coordinate the execution of chemical and microbiological sampling activities and lead all aspects of the accurate compilation of related documentation.

Management of Dependent Personnel

• Lead, coordinate, and motivate the dependent structure. Define objectives, improve results, and address training and development needs to ensure high performance.

Relations:

Internal

• Planning

• Quality

• Maintenance

• Engineering

External

• Suppliers

Requirements and Qualifications:

Essential

Studies/Diploma/Training Courses:

• Degree in CTF, Chemistry, Chemical Engineering, or a Diploma with relevant experience.

Technical and IT Knowledge:

• Proficiency in the main software applications.

Professional Experiences:

• New graduates are welcome, or a few years of experience in similar departments.

Languages:

• Proficiency in English.

Personality Traits:

• Proven leadership and group management skills.

• High sense of responsibility and availability.