Quality Manager

3 weeks ago


Princeton, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed

Ability to work independently on problems and issues and determine acceptable solutions and approaches

Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed

Understands quality by design principles and how to define critical process parameters.

Can conduct FMEA to assess risk and identify risk mitigation actions

Complete Annual Product Quality Reports (APQR)

Review statistical analysis that measures process capability and trending performance.

Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.

Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing

Requirements:

Experience managing client/vendor relationships

Required knowledge of manufacturing/packaging operations; including environmental monitoring, drug product manufacturing/packaging, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing

Experience supporting cross-functional project teams

Experience dealing with external supply world, contract manufacturing

Product knowledge of Non Sterile Products- tablets, capsules, ointments/creams, etc.

Experience in TrackWise based system or similar systems- customer complaints, deviations, etc.

Strong Communication Skills both oral and written- Savy in electronic systems as well

Requires knowledge of Quality Systems, FDA GxP regulations and guidance for pharmaceutical manufacturing.

Requires excellent verbal/written communication, negotiation/influencing, leadership and risk assessment skills.

Experience in negotiation/influencing and management of remote third party partners

Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases

B.S. Degree in Engineering or Science or equivalent with a minimum of 5 years pharmaceutical industry experience (may include Operational/Quality/Compliance/Validation experience in pharmaceutical industry).

Experience in managing client/vendor relationships

Required knowledge of manufacturing/packaging operations in the pharmaceutical industry

Experience supporting cross-functional project teams

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