Quality Compliance - Annual Product Review

Thermo Fisher Scientific

Cincinnati, OH 45217

Posted 1 month ago

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

**Location/Division Specific Information**

Pharmaceutical Services Group - Cincinnati, OH - Day Shift

**Discover Impactful Work:**

Performs Annual Product Reviews (APR)/Product Quality Reviews (PQR) and Continued Process Verification (CPV) for commercial marketed products and prepares reports per US GMP and international GMP requirements.

**A day in the Life:**

+ Write, Review and approve APR, PQR and CPV reports.

+ Ability to collect data from various resources.

+ Clearly and accurately communicates the results of work by detailing activities, data and conclusions.

+ Assures completed reports are sent and harmonize with Clients regarding questions related to the content of the reports or trends noted

+ Collaborate with a variety of resource owners to collect and interpret data and prepare reports.

+ Maintains APR/PQR/CPV files.

**Keys to Success** :

+ Incumbent must have a proven knowledge of cGMP regulations and quality systems.

+ A good understanding of manufacturing operations as well as quality operations is required.

+ Able to read and interpret relevant regulations.

+ Familiarity with Batch Records and the ability to use or learn LIMS, TrackWise, Discoverant, Microsoft Excel, SAP, and SAS/JMP/Minitab is required.

+ Able to interpret raw data and recognize trends or issues to be addressed.

+ Must be a self-starter and able to work independently.

+ Able to influence others to address recommendations in the report.

+ Have excellent technical written communication skills in English.


Minimum of a Bachelor’s degree, preferably in a scientific field with relevant experience in pharmaceutical Manufacturing or Quality.


Minimum of four years’ experience in Quality Assurance, Quality Control and/or in a pharmaceutical manufacturing or FDA regulated industry. Experience in preforming Annual Product Review/Product Quality Review and/or Continued Process Verification (CPV) is helpful.

**Knowledge, Skills, Abilities**

+ Able to communicate clearly with internal and external partners regarding content of CPV/APR/PQR for reports.

+ Good critical and logical thinking skills.

+ Effective written, interpersonal, and presentation skills.

+ Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

+ Strong statistics knowledge and experience with Minitab.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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