These roles are located in San Antonio. Direct hire
Candidate will assume a leadership role in a highly motivated group within a leading contract manufacturing facility. Major Job function includes the ownership and oversight of qualification and validation activities required to support the business and customers, including: the generation, execution, and development of the final reports for qualification / validation documents associated with cleaning, process, and packaging validation to support the manufacture of liquids and semi-solid pharmaceutical products. The individual will be required to support and / or generate technical protocols, memos and other documents in support of the qualification, validation, change control and / or 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.
– Provide 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 within the company procedures, guidance documents and industry practices. Strong communicational skills are required to effectively support cross functional teams.
– Assist and support scheduling qualification/validation activities with cross-site departments.
– Interface with clients and management as well as transfer discussions, timelines, activities to team members. This includes the timely organization of team activities, determining priorities, assignment of projects, etc.
– Organize team meetings, delegate assignments, and generate performance reviews. The individual must be able to effectively communicate expectations and objective, effectively motivate individuals, and build team camaraderie.
– Provide expertise and leadership for projects involving facility, equipment/utility qualification, and process, packaging and / or cleaning validation. Must ensure all cGMP systems within the facility are within and maintain a validated state.
As a multi-functional group, time management skills are a must. The individual must be able to effectively manage personal activities as well as manage the time of the group. The candidate must be able to report project status and team performance capability to cross functional team members.
The candidate must be familiar with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.
The candidate MUST have direct experience independently generating and executing protocols, review of data, and generating final reports for cleaning, process and packaging validation.
The candidate MUST be an independent thinker and have a strong understanding of industry regulations and guidance.