QA Manager

Ensures that AstraZeneca products are manufactured and packed according to
GXP, all local, external regulations, company policies, and are meeting the
required specifications through continuous follow-up of all activities
throughout the site.
* Perform Internal and external audits in addition to audit program planning. Prepares the audit and observation reports. Follows up audit action plans.
* Batch records revision and release of AstraZeneca Egypt products to Egyptian market.
* Prepares, updates, and approves the QA and GMP SOPs, instructions, records and logbooks.
* Act as system owner for QMS processes as per the QA task distribution plan (e.g. Managing Quality incidents, Complaints, lab investigation investigations, change, etc).
* Participate in setting the site's GMP training plan according to business priorities. Provides GMP training to site employees.
* Follows up and support the embedding of quality culture by ensuring the right behaviors are followed at all stages of operations, awareness, and proper documentation.
* Address trends of GMP observations and incidents. Provides guidance for issuing the site's improvement plans.
* Contribute in problem solving & investigation after any incidence and approves investigation report.
* Follow up CAPA implementation.
* Participate and ensure the validation of all products and processes. Follow up of validation and qualification activities till completion and issuing final reports
* Responsible for the safe archive and maintenance of validation and qualification documents in accessible protected cabinets.
* Participate in preparing Annual Product Review reports.
* Facilitates the Quality council meeting.
* Participate in Lean Project as per the site's Lean plan.
* Support new QA officers by training for GMP and SHE BY coaching and complete their objectives
* Local recall administrator as deputy for QA/QC manager
* Lead the QA daily PDR and monitors the effectiveness of the QA daily tours in Production.
* Following SHE policies, Adhere and follows Code of conduct
* Ensure own work is compliant with health, safety and cGMP
* Perform all the required activities in accordance with the local regulatory requirements.
* Receive and Respond to the updates of the regulatory decrees and laws according to the local instructions.
* Ensure that imported bulks, API's and finished goods packed from imported bulks are released to the local market according to the requirements of the health authorities.
* Perform all required risk assessment studies in accordance with the local procedures.
* Own, monitor and follow up on the identified site quality and / or other risks
* Ensure smooth business process with the regulatory assurance team through facilitation of the QA-regulatory forums
* Special tasks for the person
* Review and approves the Plant Master File
* Run the GMP letter of assurance process
* Acts as Quality and Compliance Group Policy Leader.
* Acts as Registered Quality Manager in the MoH.
* Accountable for the site's GMP license.
Essential:
* Academic / Professional qualification: Bachelor degree in pharmaceutical sciences.
* Working experience: minimum ‎10 years experience in Pharmaceutical industry (QA) including at least ‎2 years in a managerial QA role.
* Technical / skills training: Business knowledge/ GMP knowledge/ Production knowledge / Project Management
* SHE knowledge, Risk Management
* Good analytical skills/ problem solving /Leadership
* Good communication, conflict management, stress management, planning and time management skills