Proclinical is currently recruiting for a Production Lead for its client located in West Point, PA. Successful candidate will be responsible for overseeing clinical packaging operations as well as completing compliance and quality-related tasks within the Global Clinical Supplies Packaging group, including personnel scheduling and training, ensuring preparation of investigational drug products meets current quality standards, investigating clinical complaints and deviations, developing corrective/preventive actions, and updating Standard Operating Procedures.
- Ensure personnel are adequately trained
- Manage/schedule personnel for GMP activities
- Oversee and manage the GMP compliance of staff
- Author SOPs within the functional area
- Manage the ordering and inventory levels for secondary packaging components
- Provides Quality oversight to the Packaging area through the following:
- Perform complaint and deviation investigations with a focus on true root cause, and creation of appropriate CAPA's. Drive CAPA's to closure
- Ensure clinical supplies are processed according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies.
- Participate as subject matter expert during internal or external audit from Quality group, safety bodies or regulatory agencies
- Generate and oversee the change controls necessary for movement or modification to existing packaging equipment
- Support creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles as they relate to clinical supplies and participates in adjustment of logistics pertaining to drug supply. May involve liaison with Global Clinical Supplies or external partner groups
- Contribute to the Global Clinical Supplies packaging, labelling and distribution strategy through participation in process, providing expert technical review and approval of proposals.
- May represent Global Clinical Supplies on cross-functional teams or represent Operations group on internal teams as appropriate. Will undertake specific projects within the group on as needed basis
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 Samantha Reader at (+1) 267-983-0134 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.