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QA Commercial Team Leader

4 weeks ago

Horsham, United Kingdom Thermo Fisher Scientific Full time

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

Job Title: QA Commercial Team Lead

Position Location: Horsham

Thermo Fisher Scientific Inc. (NYSE: TMO) 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 analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

When you’re part of the team at Thermo Fisher, you’ll do outstanding important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

**What will you do?**

Under direction of the QA Commercial Operations Manager, proactively lead the execution of tasks by, and development of, the team of Quality Assurance Commercial Associates.

Ensure the timely and accurate activities relating to the review of Batch Records in support of commercial production and in accordance with the packaging schedule.

The post holder will work to agreed commercial client timelines, commercial client specific and Thermofisher procedures.

**Responsibilities**:

- Proactively handle the workloads of QA personnel within QA Commercial, communicating frequently with fellow QA/QC leads to ensure maintenance of the ‘flow to work’ approach enabled via the utilisation of cross-trained personnel, advancing any concerns to the attention of the Manager.
- Harmonise with the Project Managers to ensure that the QA team is appropriately allocated to meet operational demands, and that key projects are aligned between QA and the Operational functions.
- Represent the secondary level of ‘Quality’ customer concern in response to any issues / events identified during Operational activities.
- Develop, coach and mentor in line with the QA site Operations Manager, ensure training is provided to ensure individuals are appropriately equipped with both technical and ‘soft-skills’ required to meet the requirements of the job role and help their individual development plans.
- Lead the induction programme of new starters in conjunction with other QA/QC Leads.
- Quality performance monitoring and liaison to resolve quality issues with third party service providers and internal customers.
- Create and update relevant SOPs for QA commercial operations.
- Familiarity with systems such as Trackwise, Documentum and SAP etc.
- Batch Record Review and working with operations to ensure there is no delay in having the commercial batches passed onto the Qualified Person.
- Assistance in creating new batch records for new clients and products and in creating / update procedures to ensure these are fit for purpose.
- Assist investigation of deviations associated with packaging, ensuring that issues are appropriately identified and resolved, referring to management where appropriate.
- Resolution of client observations on deviations post approval and of client observations on batch records following post-production review.
- Audits - Assist in internal, supplier and client audits.

**Minimum Requirements/Qualifications**:

- Extensive knowledge of GMP environments.
- Able to analyse problems and define solutions.
- Able to work and to support others within the team.
- Good communication skills both internally and externally.
- Ability to work without direct supervision / on own initiative within the remit of the role.

**Experience required of/in**:

- Secondary Packaging Batch Record review within a pharmaceutical setting.
- Experience working within the pharmaceutical sector, or another lifecycle sector.
- Experience working with Operational colleagues and the ability to resolve discrepancies within batch records.
- High degree of accuracy, concentration, verbal and written communication.
- Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._

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