AT01-101322 Quality / C&Q Lead - "Hands On - On the Field" Professional

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality / C&Q Lead

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 10 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Extensive experience in Commissioning and Validations.
• Responsible for defining the validation strategy, C&Q plan and deliverables required to handover the project on time.
• This also includes implementation of qualification and validation activities that complies with the GxP policies and local guidelines.
• The role requires follow up of the internal and external Engineering/C&Q deliverables.
• Experience in Validation Master Plans.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Hands-on Professional.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Strong knowledge (according to related area). 
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

• Creating long- and short-term plans, including setting targets for milestones, adhering to deadlines and allocating resources.
• Delegating tasks on the project to employees best positioned to complete them.
• Identifying and managing potential risks and liabilities of multiple projects.
• Assisting in the definition of project scope and goals.
• Making effective decisions when presented with multiple options for how to progress with the project.
• Serving as a point of contact for teams when multiple units are assigned to the same project to ensure team actions remain in synergy.
• Communicating with executives or the board to keep the project aligned with their goals.
• Performing quality control on the project throughout development to maintain the standards expected.
• Adjusting schedules and targets on the project as needed.
• Motivating people involved in the project to complete tasks on time.