Assists QA&QC manager in all aspects of Supervision of Department and employees.
Performs manufacturing investigations.
Provides the Quality Assurance Team the assurance that manufacturing is carried out in accordance with cGMP and Regulatory commitments and that production records provide full and accurate documentation of batch manufacture in accordance with work instruction Remains current with all pertinent standard operating procedures relating to batch record review and QA system.
Assists in regulatory inspections as needed.
Evaluates addressed deficiencies for potential impact on compliance status. Work with
Manufacturing and/or QC to correct any noted deficiencies/inconsistencies.
Monitors trends and identify problems in quality of Utilities, water system and environmental
data and promote action having regard to changes in processes, facilities, equipment
and procedures.
Ensures compliance with current Good Manufacturing Practices (cGMP), Company Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs) and authority
regulations and guidelines.
Follows up the annual calibration plan .
Evaluates CAPA responses to the assessment findings for adequacy, including root cause and
timelines. Evaluates observation issues to management as appropriate.
Performs follow up audits (as required) to confirm corrective actions are effective..
Identifies and manages continuous improvement projects with the objective of achieving
quality, reliability and cost improvements..
Ensures compliance with all Company policies and procedures, including safety rules and
regulations.
Assists in the development, implementation and enforcement of validation policies and
practices.
Coordinates validation activities between internal departments.
Generates documentation to support the qualification of equipment, facilities and
critical utilities.
Assure calibration system is current and maintained.
Assess the performance of QA Staff, recommends further training and practice to enhance
their competency.
Monitors performance by gathering relevant data
and producing statistical reports.
Job Details
| Date Posted: | 2015-04-29 |
| Job Location: | Cairo, Egypt |
| Job Role: | Quality Control |
| Company Industry: | Pharmaceutical |
Preferred Candidate
| Career Level: | Management |
| Nationality: | Egypt |
| Degree: | Bachelor's degree |
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