Mgr, Validation

Organization: 
Allergan
Job Location: 
Fall Rive, MA
Job Description: 

Manages and coordinates through subordinates the validation activities at the Allergan Fall River plant site, to ensure that all validation and associated activities are performed within budget, regulatory guidelines and within established time lines.

Job Details

This position will be responsible for all validation activities related, but not limited to: New products, new processes, plant validation/re-validation activities, new equipment/systems. Responsible for creating and maintaining the site validation Master Plan. Generates, on a timely basis and according to project needs, Validation Protocols, reports, project Gantt charts, etc. Provides support for critical projects, marketing (justification for packaging changes), Worldwide Specifications, Worldwide Manufacturing Support and Worldwide Quality Assurance. Develops and administrate the department?s budget, sets up department goals, interprets administrative policies for employees including but not limited to hiring, terminations, promotions, work performance reviews, safety, etc. When required, will support supplier audits/appraisals and internal audits.

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

Regulated Responsibilities (including cGMP and EHS)

Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485:2003- Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), Canadian Medical Devices Conformity Assessment System (CMDCAS), OSHA, Sarbanes-Oxley, EPA, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Requirements:
Education:

B.S. degree in Chemistry, Microbiology, Engineering, or related science fields

Education
B.S. degree in Chemistry, Microbiology, Engineering, or related science fields

Experience
Ten (10) years exposure in Validations of pharmaceutical manufacturing products. Such as Aerosol Manufacturing, sterile pharmaceutical products, semisolid manufacturing etc