Mennatallah Aziz Maklad

Hochster

• Quality Assurance Section HeadFull Time

  Jan 2019 - Present -6 yrs, 8 months

  Egypt , Cairo

  • Job Details:1. Supervise the manufacturing process and ensure that it is done in accordance with the GMP guidelines and that all the processes within Hochster are done in accordance with GxP guidelines. 2. Supervise batch manufacturing record review and review necessary documentation for batch release. 3. Handle CAPA visits and follow-up the different requirements of CAPA and NODCAR, in coordination with other departments. 4. Release the manufactured batches for local and export markets. 5. Approve the manufacturing formulas on Oracle system. 6. Plan and conduct self-inspection, supervise follow-up and confirm the execution of the necessary actions until the closure of the NCR. 7. Handle deviations, complaints, NCRs and OOSs and confirm the execution of the required actions after proper investigation. 8. Create and manage a quality risk management system that continuously identifies, analyzes, evaluates, controls and communicates GxP risks. 9. Follow up and report the quality KPIs from all the departments to the top management periodically. 10. Cooperate in change control and follow-up the implementation of the required actions including any validation needed. 11. Review and analyze the annual review for all products manufactured in Hochster. 12. Escalate the critical quality issues to the top management and where necessary, take the proper actions to mitigate them. 13. Training the QA team and following up the annual training plan 14. Planning and conducting audits on suppliers and other entities. 15. Management of external audits by regulatory bodies and business entities. 16. Planning and follow up of the quality objectives whether short-term, long-term or strategic in cooperation with top management. 17. Conducting annual GxP training programme for the technical staff. 18. Being the pharmacist responsible for narcotics dispensing; dispensing narcotic raw materials in the attendance of the MOH representative, and following-up the narcotics batch records revision.
• Quality Assurance SupervisorFull Time

  Jun 2016 - Dec 2018 -2 yrs, 6 months

  Egypt , Cairo

  • Job Details:• Handling MoH inspections and requirements both from CAPA and NODCAR, in coordination with regulatory affairs, quality control and production departments. • Handling the review and release of batch manufacturing and packaging records and ensuring that all the related documents are available. • Revising and approving packaging materials. • Ensure strict adherence to Hochster standard operating procedures & cGMP principles • Collate data on aspects of the quality management system for incorporation into regular periodic reports • Performing extrinsic audits on packaging materials suppliers. • In cases of deviation, writing deviation report and RCA, then work actively with managers and engineers from all disciplines in resolving corrective actions and timely completion of these reports. • In cases of failures, implementing and following-up documented corrective actions. • Writing, reviewing and updating SOPs regarding QA documentation compliance, and validation. • Participates in the internal audit program according to ISO 19011. • Training QA junior staff. • Being the pharmacist responsible for narcotics dispensing; dispensing narcotic raw materials in the attendance of the MOH representative, and following-up the narcotics batch records revision. • Ensure employees awareness of quality policy. • Observing and complying with company Health and Safety policies
• Senior QA SpecialistFull Time

  Jan 2015 - Jun 2016 -1 yr, 5 months

  Egypt , Cairo

  • Job Details:• Handling the review and release of batch manufacturing records. • Revising and approving packaging materials. • Ensure strict adherence to Hochster standard operating procedures & cGMP principles • Collate data on aspects of the quality management system for incorporation into regular periodic reports • Creating APRs for different products manufactured by Hochster. • Performing extrinsic audits on packaging materials suppliers. • Preparing retrospective process validation protocols. • In cases of deviation, writing deviation report and RCA, then work actively with managers and engineers from all disciplines in resolving corrective actions and timely completion of these reports. • In cases of failures, implementing and following-up documented corrective actions. • Writing, reviewing and updating SOPs regarding QA documentation compliance, and validation. • Participates in the internal audit program according to ISO 19011. • Training QA junior staff. • Being the pharmacist responsible for narcotics dispensing; dispensing narcotic raw materials in the attendance of the MOH representative, and following-up the narcotics batch records revision. • Ensure employees awareness of quality policy. • Observing and complying with company Health and Safety policies
• QA SpecialistFull Time

  Jan 2014 - Jan 2015 -1 yr

  Egypt , Cairo

  • Job Details:• Ensure strict adherence to Hochster standard operating procedures & GMP principles, related to operation & cleaning of production equipment & rooms. • Ensure GMP compliant start-up production area & set-up of machines. • Dispensing released raw materials for production. • Verify strict adherence to processing & packaging instructions stated in the approved batch manufacturing records, through performing the double check on time. • Check in-process testing done by production technicians by performing testing, reviewing test data, and writing investigations according to SOPs and GMP. • Performing in-process tests for solid and liquid dosage forms (Solid: disintegration, hardness, thickness and friability tests for tablets and leakage tests for blisters) (Liquid: volume, torque and leakage). • Record results in batch manufacturing records. • Supervising the drug preparation steps in cooperation with production pharmacists. • Writing and updating SOPs regarding QA documentation compliance, and validation. • Participates in the internal audit program according to ISO 19011. • Ensure employees awareness of quality policy. • Assist in extrinsic audits on packaging materials suppliers. • Participates in the batch records reviewing & data compiling to submit the batch file to quality manager for final release • Being the pharmacist responsible for narcotics dispensing; dispensing narcotic raw materials in the attendance of the MOH representative, and following-up the narcotics batch records revision.
• Regulatory Affairs SpecialistFull Time

  Nov 2011 - Jan 2014 -2 yrs, 2 months

  Egypt , Cairo

  • Job Details:- Submitting all required documentation for Hard Files and following up till getting the final license. - Editing and translation of EMC/ FDA insert leaflets and approving them by CAPA. - Following up with NODCAR for product analysis. - Designing and editing of drug packaging according to the regulations of CAPA. - Updated with FDA/ EMA/ Rote Liste and checking the daily drug approvals. - Writing brief scientific research about the potential molecules that can be added to the company's products. - Preparing a primary market study for potential molecules that can be added to the company's products. - Submitting and following up with stability files. - Preparing Drug Soft files - Good knowledge of the eCTD system.