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Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.
The Validation Manager is responsible for ensuring that the Drug Substance Operations (DSO) facilities, equipment, analytical methods and processes are validated and maintained in accordance with all WWQA standards, Ministry of Health regulations and emerging trends within the industry. The incumbent will provide management and career guidance to the DSO Validation staff, and manage the project contractors.
The incumbent will:
- Develop and maintain the overall DSO validation program for computer systems, facilities, equipment, manufacturing processes and cleaning activities
- Apply a risk based (phase appropriate) approach to the validation activities for early stage products
(PhI-Ph-II)
- Work with Allergan SMEs to develop and execute analytical method validations
- Oversee the validation activities at Allergan contract manufacturing sites
- Ensure timely review and approval of DSO validation protocols/reports, Master Plans and SOPs
- Support regulatory changes through the provision of necessary validation documentation and change control activities
- Be responsible for the defense of the program and all executed protocols and reports during regulatory inspections and internal audits
- Establish and oversee continuous improvement initiatives as appropriate for the validation of DSO manufacturing processes, equipment, facility, utilities, and control systems
- Monitor and report to upper management on validation related projects
- Provide hands on support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements. Collect and analyze data to make data driven recommendations/decisions.
- Conceptualize and create validation strategies for validation project teams. Use engineering or scientific background to understand the technical aspects of validation to create strategies consistent with the operational and compliance needs.
- Build and maintain successful cross-functional relationships with internal customers such as BP, BPS, DSO Quality/Manufacturing, CMC, Westport, Regulatory and WWQA
Must be able to lead the department in addressing technical issues and working successfully with Operations, Manufacturing and R&D on manufacturing and engineering programs
- BA / BS in a scientific or engineering related field
- 10 to 14 years work experience in Quality Assurance or Engineering, and a minimum of 7 years of experience in the pharmaceutical or biopharmaceutical industry. the a GMP regulated environment
- Five years of specific validation experience is also required
- Experience using statistical, risk assessment, experimental design and process improvement tools is also required.
- Communication: Excellent written and verbal communication skills at all levels. Effectively communicates both up and down the organization and maintains a customer focus.
- Collaborative Leadership: Ability to influence with or without authority, manage expectations and ensure alignment.
- Hands on Experience: Direct experience in the creation and execution of validation protocols. Previous experience with Ministry of Health (MOH) inspections and responses.
- Planning and Organization: Excellent planning and prioritization skills with the ability to multi-task and adapt.
- Analytical Problem Solving: Ability to identify, define and resolve problems using a structured methodology.
- Technical Expertise: Thorough understanding of validation concepts, current and emerging trends
- Ability to travel approximately 25% - 35% of the time.
EEO/AA M/F/V/D
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