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Validations Manager
Site Leader Role as our Validations Manager – San Antonio, TX (Relocation Available)
Novotus has partnered with DPT Laboratories to immediately locate a Validations Manager for our growing business offering contract development, manufacturing, and packaging to the pharmaceutical and bio-technology industries. This opportunity plays the lead role in our San Antonio facilities and reports directly to our Director of Quality in Lakewood, NJ. We seek your new ideas and modern approaches to optimize our existing processes while building synergy with our other corporate departments.
DPT, a division of DFB Pharmaceuticals, has been in existence since 1990. We have steadily grown to become the leading contract development and manufacturing organization (CDMO) in liquids and semi-solids.
Function: Major job functions include: overseeing and participating in the generation, execution, and development of final reports for qualification/validation documents associated with equipment, utilities, systems, and processes in place to support the manufacture of multiple lines of: solids, liquids, and semi-solid pharmaceutical products. You will be required to support and generate technical protocols, memos and other documents in support of the qualification, validation, change control, and other quality engineering related tasks. Projects range from stand alone equipment to expansion, new packaging lines and new product launch. Coordinate and supervise cross functional resources in the execution of validation cGMP projects and ensure compliance with FDA, ISO, EU and any other appropriate regulations. Technical assistance for investigations into process/product issues in support of the qualification/validation deviations and review of design requirements for products and or equipment.
Schedule, plan, and resource load of activities to support qualification/validations efforts as needed, including assisting in process sampling, auditing and technical review functions as defined in study protocols. Strong communicational skills are required to support cross functional teams effectively. Assist and support scheduling qualification/validation activities with cross-site departments.
Candidate will provide expertise and leadership for projects involving facility, equipment/utility qualification, and process, packaging and/or cleaning validation. Must ensure all systems maintain a validated state.
Candidate must be familiar with current industry practices and guidelines including those required/outlined by the FDA, ISO, EU and ICH.
Accountabilities:
Execute and prepare protocols and interpret results
Must be proficient at word processing and Project management
Must have strong Technical writing skills
More than 5 years experience direct supervision/leadership ability
More than 10 years pharmaceutical industry experiences coupled with at least 5 yrs direct (i.e. “hands on”) validations experiences
This opportunity will be managed by Novotus. If this position seems like a good fit for you, please apply through our online process and a Novotus Representative will be in touch with you soon with the next steps.
To apply, follow this link: http://budurl.com/VMSanAntonio
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Position Type:
Employee
Ref Code: 3094 |
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