Quality Assurance Manager
Hi Pharm -
Cairo, EgyptPosted 6 years ago162Applicants for1 open position
- 153Viewed
- 3In Consideration
- 128Not Selected
Job Details
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Job Description
- Manages personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Implements and maintains the Document Control system and GMP Training program and processes to ensure high quality products and compliance with current GMPs.
- Writes and/or implements changes to controlled documents to ensure defined quality objectives are met.
- Collaborates with Senior Management teams to ensure optimal tracking of training records.
- Designs, develops and delivers high quality and high impact learning products, programs and services that provide functional, GMP and product knowledge for staff to achieve a high level of performance in their jobs.
- Evaluates the effectiveness of trainings, implementing modifications when necessary, and monitors training compliance for staff.
- Maintains systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems.
- .Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
- Manages the document periodic review process.
- Manages the collection and maintenance of department metrics.
- Provides support with internal and regulatory audits and inspections as required.
- Leads project team within functional area, as needed. Participates in cross-functional teams as appropriate for own functional area.
- Keeps abreast of the requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.
- Follows Validation. Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Notifies manager of all observed hazardous conditions or unsafe work practices.
- Performs other related duties and assignments as required and defined by management.
- Develop, coordinate implementation, and monitor a ISO quality system throughout the facility
- Follow all MOH standards and regulations which related to the manufacturing process
- Coordinate all QA activities and ensure all established SOP and procedures are being applied.
- Organize internal audit plans and inform top management about the results and follow up the agreed corrective actions.
- Coordinate and respond to regulatory, client, and third party quality assessments.
- Ensure all documents are controlled and revised regularly.
- Responsible for finished products release for sales
- Act as recall coordinator, responsible for keeping recall procedures up to date
- Organize the validation procedures and applications.
- Coordinate IQ/OQ /PQ and periodic qualification and/or calibration of factory equipment.
Job Requirements
- Bachelor of pharmaceutical
- Required Experience, from 7 to 10 years in Pharmaceutical industry.
