Workstream Leader Production and Process Controls
Proclinical is currently recruiting for a Workstream Leader Production and Process Controls with a leading medical technology company located in St. Louis, MO. Successful candidate will assume a leadership role to manage projects in support of the development/implementation of quality/manufacturing processes of new Auto Injectors products at the site. In addition, this position will also manage projects to maintain existing Auto Injector products to be in compliance with regulations and or customer requirements.
- Manages/leads key projects utilizing effective project management tools in order coordinate the introduction of new processes and products into the site.
- Ensures project plans are developed and maintained to meet the needs of the site and customer using appropriate risk mitigation strategies.
- Conducts routine project review meetings with team members to ensure timelines and projected costs are met.
- Assess risk and ensures that issues are discussed within the team and with the sites leadership.
- Drives project team accountability.
- Ensures that the project teams interact with the sites Validation, Manufacturing, and Quality, Technical and Regulatory departments, at appropriate levels, to ensure execution of project tasks.
- Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
- Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
Skills and Requirements:
- BS/BA, MS or PhD in a relevant discipline.
- A minimum of 10 years of pharmaceutical development and or manufacturing experience in a cGMP or medical device environment is required for this position.
- Knowledge of cGMPs and regulatory requirements as related to the manufacture, testing and quality of parenteral products.
- Good interpersonal skills; collaborative approach; team player.
- Demonstrates attention to detail.
- Excellent organizational skills.
- Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies.
- Demonstrates self-sufficiency, able to work under limited supervision.
- Experienced in meeting the expectations and requirements of internal and external customers.
- Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.
- Deals with concepts and complexity comfortably - intellectually sharp, capable and agile.
- Understands when to inform, consult or escalate. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance.
- Presentation skills, computer literate (MS WORD, Excel, PowerPoint, QTS, Lotus Notes).
- Review and approve cGMP Changes in accordance with regulatory requirements
- Review and approve training to assure cGMP requirements are met.
- Ensure all drug products comply with applicable compendia requirements and are manufactured under cGMPs.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613, M.Kelly@Proclinical.com or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.