Ensure supervisory and effective/efficient planning of analytical activities of utilities and starting materials (Packaging materials, Excipients and API / DS), through the planning and control of the progress of daily activities, in order to meet OTD/RFT (on time delivery / right first time) of the manufacturing plan and client requests.
The QC Packaging & Raw Material Team Leader works with the Manufacturing Planning team to make raw materials available for manufacturing activities
**What will you do?
**
- Ensures both the execution and constant supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements, supporting analysts in problems solving for analytical activities relating to API / DS, Excipients, Packaging Materials, materials GMP, utilities
- Draws up analytical specifications, study protocols and reports, analytical methods and SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
- Coordinates with the Supervisor the customer's management with the aim of maintaining a high level of customer satisfaction and completing the required activities on schedule
- Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise
- Collaborates with the Supervisor to identify the requirements for analytical technology transfer from customers, then ensuring the correct and effective transfer to the laboratories
- Collaborates with the Supervisor in managing laboratory investigations (Out of Specification and Deviation Reports)
**How will you get here?
**
- Degree in CTF, Chemistry, Biology or other similar fields Diploma Chemical/Laboratory technician certificate
- Experience in pharmaceutical industries
- Multi-year experience in Quality Control
**Knowledge, Skills, Abilities**
- Knowledge of the main techniques of chemical-physical and biochemical analysis and validation of analytical methods
- Knowledge of GMP and national/international regulations
- Good problem-solving abilities
- Proficiency in Microsoft Office suite and both analytical and statistical software (Empower, MiniTab, Sample Manager)
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment