Req #: 180008XE_en
RESUMEN GENERAL (SUMMARY):
Develop, coordinate and manage overall plant effort and programs to assure full compliance with Corporate, Division and FDA regulations. Develop, coordinate and manage plant process documentation to assure on time product availability. Manages, coordinates and execute listed duties and responsibilities. Assign tasks to subordinates. Evaluates subordinates performance and performance problems and takes appropriate corrective actions. Support areas of product manufacturing such as: Injection Molding, Extrusion, Prep Room, Heat Seal and all sub assemblies.
TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSABILITIES):
1. Manage engineering resources to set workload priorities in areas of responsibilities as established by Management.
2. Initiates or recommends special studies and analyses of new products or processes to evaluate quality attributes on product reliability.
3. Help to coordinate activities during regulatory inspection with the Quality personnel.
4. Evaluates and assures product’s quality through quality indicators and keeps product release performance within standards.
5. Responsible for the preparation and administration of the area Quality Group.
6. Develops and manages VIP objectives and monitors implementation results.
7. Monitor and approves all related manufacturing and quality Standard Operating Procedures and compliance.
8. Controls SPC, Six Sigma and CPK concepts until its final implementation.
9. Represent the company as a coordinator during FDA inspections and maintain a proper communication that creates an atmosphere of credibility and confidence.
10. Assist the Plant Quality Director in the evaluation and decision towards the acceptability or rejections of products.
11. Assure quarterly Quality System Management reviews are in order to identify areas for opportunities, both for productivity and quality improvements, supporting our facility quality improvement process.
12. Coordinates and evaluates new projects with pertinent plant personnel.
13. Prepares and participates in management presentations. Prepares and controls budget of responsibility areas.
14. Assists Quality Director in the preparation and administration of department's budget. Interviews and hires new personnel for responsibility area. Revises specifications and recommends changes.
15. Observes all company and regulatory EHS requirements.
16. Observe data privacy and confidentiality policies at all time.
17. Verify, support and approve investigations related to areas of responsibility.
EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):
Bachelor Degree in Science, Engineering or Business Administration. Eight to ten years of experience in Pharmaceutical Industry. Two years minimum on management and supervision. Experience in validation processes.
Must be knowledgeable of specifications, procedures and regulatory requirements (Ex. GMP, DHSS, OSHA, ISO, etc.) Knowledge of BRS (Batch Release System) and System validation process. Must have good interpersonal, communication and leadership skills. Self-motivated and self-starter. Good supervisory skills. Willing to travel occasionally.