QA Manager

Job Description

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

Date Posted06-Sep-2022Closing Date21-Sep-2022AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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