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Manager, Non Sterile- External Quality

Newark Metro Area, NJ

Post Date: 01/05/2017 Job ID: JN -012017-18049
Duties:
Experience in developing and managing client/vendor relationships from development through end of relationship.
Required knowledge of manufacturing operations; including API manufacturing, environmental monitoring, drug product manufacturing, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing.
Experience leading cross-functional project teams.
Ability to troubleshoot manufacturing process deviations and analytical OOS results as needed.
Experience dealing with external supply world, contract manfacturing
Product knowledge of Non Steril Products- tablets, capsules, ointments/creams etc

Skills:
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.
Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.
Understands quality by design principles and how to define critical process parameters.
Can conduct FMEA to assess risk and identify risk mitigation actions.
Review statistical analysis that measures process capability and trending performance.
Experience in negotiation/influencing and management of remote third party partners.
Ability to supervise work and task completion of associates or interns.
Ability to work independently on complex problems and issues and determine acceptable solutions and approaches.
Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases.
Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing.
Experience in developing and managing client/vendor relationships from development through end of relationship.
Required knowledge of manufacturing operations; including API manufacturing, environmental monitoring, drug product manufacturing, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing.
Experience leading cross-functional project teams.
Ability to troubleshoot manufacturing process deviations and analytical OOS results as needed.

Education:
B.S. Degree in Engineering or Science or equivalent with a minimum of 8 years pharmaceutical industry experience (may include Operational/Quality/Compliance/Validation experience in pharmaceutical industry).

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