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description
The quality executive job description includes elements such as: quality
executive responsibilities, quality executive skills, quality executive qualities,
quality executive abilities, quality executive experience, quality executive job
tools, quality executive working conditions
Set both short term and long term objectives / vision / priorities for QA / QC depts
Manage / Host FDA inspections and audit responses / commitments as well as
customer audits.
3. Coordinate regulatory actions if required Field Alerts, Recalls, etc. ; escalate to Sr.
mgmt
4. Accountable for all batch release / critical quality decisions
5. Review / approve major / critical laboratory / non-laboratory deviations
6. Management / oversight of critical customer product complaints (Field Alerts)
7. Review / approve validation documents as required (EQ, PV, CV, etc)
8. Support continuous improvement initiatives at site to promote both efficient and
compliant operations
9. Ensure site specific compliance with all corporate policy documents and requirements
10. Ensure all Quality Operations stay current with regulations, cGMPs, current FDA
expectations, and industry trends ; ensure compliance with USP, ICH, etc guidelines /
requirements
11. Execute as required to meet established metrics, in support of both business and
quality priorities. Identify actions as needed to ensure improvement and objectives are
met.
12. Ad hoc responsibilities as assigned by Sr. Management.
2. Components of KSA:
Knowledge
A body of information needed to perform a task.
For example, Human Resources Knowledge include knowledge of personnel
recruitment, selection, training, compensation and benefits, labor relations and
negotiation, and personnel information systems.
Skills
Skills are the proficiency to perform a certain task.
For example, skill in operating computer peripherals such as printers.
Abilities
Abilities are an underlying, enduring trait useful for performing tasks.
For example, oral comprehension the ability to listen to and understand
information and ideas presented through spoken words and sentences.