Supervisor, Qc Stability

1 giorno fa

Lazio, Italia Thermo Fisher Scientific A tempo pieno

When you're part of the team at Thermo Fisher Scientific, you'll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs for treatments for all patients, including children always pointing our attention to save lives and giving to many people big hope for a healthier future.
Your work will have real-world impact, and you'll be supported in achieving your career goals
**Location**:
Ferentino, Italy
**How will you make an impact?
**
The position is responsible to lead and coordinating of the QC DPS chemistry operations teams through a powerful and efficient planning and progress control, to meet OTD/RFT (timely delivery / right first time) and client requests.
**What will you do?
**
- Ensures the constant supervision of analytical laboratory activities in accordance with GMP requirements
- Reviews and approve analytical specifications, study protocols and reports, analytical methods and SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
- Ensures the requirements for analytical method validations and technology transfer from customers, then ensuring the correct and effective transfer to the laboratories
- Collaborates in managing laboratory investigations (Out of Specification and Deviation Reports)
- Coordinates with the laboratory Manager the customer''s management with the aim of maintaining a high level of customer happiness 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
- Defines the QC laboratory capacity in order to guarantee the assignment of the new incoming projects to the QC teams, execute, according to new business and additional analytical services, an accurate and deep evaluation of the associate incoming workload to support the S&OP process
- Ensure effective management of the Team and resources assigned
- Collaborate with the Manager to define the Teams structure and organization based on the department workload
- Collaborates with the Manager in the assessment and evaluation of internal metrics and their presentation and discussion within the periodic Site Quality meetings
- Collaborates with Manager to define the Annual Operating Plan (AOP), budget and CAPEX for the QC department
- Participates to internal meetings to support the discussion on new QC business/projects by evaluating the impact on laboratory capabilities in terms of equipment and resources; provide with QC feedback on new proposals, change of scope and Project expansion (PE)
- Supports PPI initiatives for process optimization
- Participates in internal, Client and regulatory Audits
**How will you get here?
**
- Degree in CTF, Chemistry, Biology or other similar fields
- 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 and Team Management skills
- 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
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, increasing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Our distributed team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Thermo Fisher Scientific is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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