- Analytical methods development
- Analytical methods validation according to ICH guidelines.
- Coordinate all equipment and facilities validation activities as related to plant operations.
- Review and approve all protocols, reports and studies as prepared and conducted for equipment and facilities validation.
- Perform validation assessments for all equipment and facilities related change controls.
- Review, revise and develop Standard Operating Procedures (SOPs)
applicable to equipment and facilities validation and assist in the review and development of plant-wide SOPs.
- Oversee, review and approval of the site Validation Master Plan and Validation Project Plans.
- Support the generation of risk assessments for various equipment and facilities related validation activities.
- Represent validation during agency and client audits (as needed) on matters pertaining to equipment and facilities validation
responsibilities. - Coordinate and track the corrective/ preventive action follow-ups to audits for equipment and facilities related validation issues and activities.
- Manage resource loading and manpower requirements associated with equipment and facilities validation activities or in support of internal / external client projects.
- This includes managing external validation
resources.
- Assist with the preparation of equipment and facilities validation budget for capital projects.
- Prepare request for proposals for external equipment and facilities validation resources.
- Review bids and prepare bid award recommendations for upper management approval.
- Determine and coordinate the training needs of employees directly involved in the functions associated with Equipment and Facilities Validation.
- Assist with the development and tracking of the department budget.
- Periodically update the management of relevant validation activities
- Support other site departments with periodic reviews and collaboration on computer system validation, aseptic media simulation programs, and environmental monitoring programs.
- Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work Plans, monitors, and appraises direct reports including performance competencies, goals & job results Coaches, counsels, and conducts disciplinary actions
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
- Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards and Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned
- May be required to assist in other departments
Skills A minimum of 5 years of experience as Validation Manager/Supervisor in the pharmaceutical industry in a validation or quality related position.
BSc Degree in Pharmacy, Chemistry or Chemical Engineering
Job Details Job Location Dubai, United Arab Emirates
Company Industry
Pharmaceutical
Company Type
Employer (Private Sector)
Job Role Quality Control
Employment Type
Full Time Employee
Monthly Salary Range
Unspecified
Number of Vacancies
1
Job Ref.
JB3830846
Preferred Candidate
Career Level
Management
Years of Experience Min: 10
Residence Location
United Arab Emirates
Degree
Bachelor's degree / higher diploma
Age
Max: 50
This job is posted in the following Specialties:
People who applied to this job also applied to
Arab Monetary Fund Abu Dhabi, UAE
Arab Monetary Fund Abu Dhabi, UAE
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Job Title Analytical Method Validation Manager - Pharmaceutical
Company Name
People who applied to this job also applied to
Arab Monetary Fund Abu Dhabi, UAE
Arab Monetary Fund Abu Dhabi, UAE
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