- 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.
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- 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.
- Surveys literature to remain current with developments in analytical instrumentation qualification and computer systems validation.
- 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.
- Performs related duties as assigned.
Education & Qualifications Required:
- Bachelor’s Degree in Science or related scientific filed from an accredited college or university, and nine (9) years related pharmaceutical laboratory experience, or an equivalent combination of education and experience.
- Responding to inquiries from management, employees and regulatory agencies.
- Working with a high degree of independence and of conceiving and achieving technical goals with little or no technical supervision.
- Training of junior staff
- Leading the activities of technical personnel; making decisions and satisfying the needs of a qualification/validation program.
- Communicating clearly and concisely, both orally and in writing.
- Operating scientific and personal computers.
- Managing multiple projects, duties and assignments.
- Coordinating and reviewing the work of assigned department personnel.
- Technical Report Writing.
- Establishing and maintaining cooperative working relationships with others.
- Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
- Pertinent SOPs related to analytical instrumentation qualification and computer system development life cycle.
- Data Integrity principals as they related to regulatory rules, regulation and guidelines.
- FDA, CGMP, and SOP regulatory rules, regulation and guidelines.
- Business, English usage, spelling, grammar and punctuation.
- Business, scientific and personal computer hardware and software applications.
- Supervision, leadership and training practices and methods.
- Current Company policies, practices and procedures, including safety rules and regulation.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.