QA Manager

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Obour City, CairoPosted 4 years ago

142Applicants for1 open position

Job Details

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Establish internal auditing plan and supervise its implementation and follow up
Analyzes, evaluates, and presents information concerning factors such as, manufacturing problems, economic trends, and design and development of new products for consideration by other members of management team.
Coordinate with MOH auditors and their activities in the plant.
Implements and maintains systems policy, processes and procedures for quality management system
Ensures timely completion of routine QA tasks regarding manufacturing, packaging , analysis and in-process testing checks, sampling and other agreed upon duties.
Reports any non-conformances to the top management that are identified during routine operations monitoring.
Ensures that all phases of manufacturing, packaging, analysis and formulation development of products comply with relevant standard operations procedures and manufacturing practices and safety guidelines.
Approve periodic review of SOPs & any other relevant GMP documents according to due dates.
Participate with other departments in issuing deviation reports, OOS reports

Approve all GMP relevant documents e.g. SOPs, MOA …..etc.
Check Vendor quality, evaluate it and perform auditing for them to share in conducting vendor data base for certified and approved suppliers.
Accompany all external or third party audits or inspections conducted on quality related processes
Review & approve of IQ, OQ & PQ done by engineering & validation departments.
Approve of validation documents,
Prepares product failure analysis; reviews and approves proposed changes to existing products.
Responsible of Annual Product Review and reporting it to Top Management
Release of starting materials, intermediate bulk and finished products on time
Reports periodically to Top Management for efficiency of QMS and its implementation
Assures an effective implementation of the recall system
Assures customer satisfaction by implementing an effective system for customer feedback & possible complaints to handle customer complaints

BS with concentration in biology or chemistry or pharmacy preferred.
Eight to ten years experience in pharmaceutical operations, including at least three years in overseeing QA compliance.
Understanding of methodologies and best QA practices
Knowledge of documentation reviews and requirements analysis.
Ability to troubleshooting and resolving complex issues effectively.
Excellent English, verbal / written communication
Ability to work well through others
Excellent computer skills