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Title Location Type Rate Apply
Sr. Manager/Assoc. Director, Validation  Orlando FL  Perm/Full $65,000 - $85,000

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Sr. Manager/Assoc. Director, Validation
• Oversee validation department and assure all operations are conducted in accordance with regulatory requirements and expectations.
• Plan, organize and manage resources on projects to assure technical and regulatory quality, budget and schedule adherence.
• Develop technical documents in accordance with regulatory requirements and guidance.
• Design, execute and summarize equipment IQ/OQ/PQ protocols for manufacturing and laboratory equipment.
• Design, execute and summarize process validations; including mixing, aseptic processing, clean in place, steam in place, WFI, HVAC and new facilities.
• Develop Standard Operating procedures for equipment and processes.
• Initiates hiring, performance reviews, and staff development activities to improve technical and management capabilities.
• Responsible for effective written, verbal, and interpersonal interactions with external clients and internal project teams.
• Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results. Participate in client and regulatory audits of facilities and quality system.
• Participate in strategic and product development planning.
• Design and implement new methodologies to increase efficiencies and productivity

Requirements:

• Minimum of Bachelors degree and 8 years of experience working in Validation
• Experience with cGMP documentation systems and with the implementation of quality systems.
• Strong knowledge of FDA manufacturing/regulatory regulations; including requirements for qualifications, facilities and investigation requirements.
• Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives.
• Must possess direct experience in analytical method development, transfer and validation.
• Must possess a strong experience base in product QC testing and release procedures/documentation.
• Must be detailed oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
• It is expected that the incumbent will have skills in HPLC, GC, and mass spectroscopy detection technologies. Familiarity with cGMP and regulatory guidance is also required. Excellent communication and technical writing skills are essential in order that this person can effectively work with multiple teams simultaneously in a highly matrixed environment. The colleague is expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications.

• Design, execute and summarize equipment IQ/OQ/PQ protocols for manufacturing and laboratory equipment.
• Design, execute and summarize process validations; including mixing, aseptic processing, clean in place, steam in place, WFI, HVAC and new facilities.
• Develop Standard Operating procedures for equipment and processes.