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Summary: Under limited supervision, participates as a team member in qualification/validation activities related to laboratory instrument/equipment systems including computer systems. The position additionally provides lead duties by providing technical assistance and training.
- May supervise, coordinate, prioritize and lead the daily activities of a group of qualifiers/validators and schedule their workloads.
- Designs qualification/validation plans and protocols; researches and writes documents in support of project directives for the qualification/validation of instrumentation/computer systems. Performs and may oversee the development of qualification/validation activities for instrumentation and supporting software.
- Develops and oversees the creation of Standard Operating Procedures related to instrumentation including the administration of related supporting software.
- Maintains appropriate documentation of records, report sheets and laboratory logbooks as required by Standard Operating Procedures (SOPs).
- Provides scientific and technical leadership to junior staff members to ensure project deadlines and performance standards are met. Collaborates closely with Supervisor to set priorities and reach objectives.
- Prepares and presents written reports on qualification/validation activities.
- Provides formal and informal training to laboratory personnel on instrumentation usage.
- Selects, justifies, and implements appropriate instrumentation, computer systems, and procedures to achieve product development support objectives.
- Ensure compliance with all Company policies and procedures, including safety rules and regulation.
- Pertinent SOPs related to analytical instrumentation qualification and computer system development life cycle.
- FDA, CGMP, and SOP regulatory rules, regulation and guidelines.
- Business, scientific and personal computer hardware and software applications.
- Supervision, leadership and training practices and methods.
- Responding to inquiries from management, employees and regulatory agencies.
- Training of junior staff.
- Leading the activities of technical personnel; making decisions and satisfying the needs of a qualification/validation program.
Minimum Qualifications:
Bachelors Degree in Science, Information Technology, or related scientific field from an accredited college or university, and 5 to 10+ years related pharmaceutical systems or laboratory experience desired, or an equivalent combination of education and experience.
Knowledge of 21CFR part 11 and GAMP5 Guidance a plus.
Pharma systems validation experience desired.
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