Senior Manager for External Quality and regulatory intelligence
Julphar
Total years of experience :16 years, 9 Months
Managing the compliance of external vendors Supply to Julphar plants RAK in addition to vendors qualification program and external auditing programs for both suppliers and distributors
Handling all submissions review for registeration, variations or renewals in MEA region in addition to quality oversight to all PV related activities for Julphar headquarters RAK
qualification of distributors and preparation of TQAs, handling all storage and distribution in Kulohar plants and at distributor sides
and Africa
• Responsible for ensuring that All quality processes and systems are implemented across the regional Functions, including / but not limited to:
•Local Complaint handling and Coordination activity (Receiving, investigating, response and closure).
•Product Surveillance activity for Drugs and Medical Devices
•Field Corrective Action execution
•Inventory management and (ERP system) expert user.
•Release of products according to GMP and QP module
•Implementation of Baxter quality system.
•Deviation and non-conformities handling.
•Change control committee chairman.
•Ensure that processes and procedures are compliant to local regulations, Corporate Quality Manual and to ISO 9001&13485 requirements.
•Ensure appropriate contacts with country functions (Regulatory Affairs, pharmacovigilance, R&D and TS) and businesses are maintained.
•Nominated as Quality responsibility for Dubai warehouse.
•QMS & Documentation
•Ensure the implementation of the Applicable Quality Manual in the MEA region. This involves the monitoring of the performance of the quality system.
•Act as Documentation Center for CQA, TS, W&D, RA and PV functions in MEA by publishing the documents in documents control system.
•Ensuring all relevant SOP's are in place to meet Corporate Quality Manual requirement and ISO 9001&13485 standards
•Preparation of new SOP's, controlling approval, distribution, obsoleting & filing of quality related documents
•Complaint and Recall Management:
•Act as regional Coordinator for Complaints and recalls.
•Notify the authorities of all reportable Complaints.
•Train the customer facing employees on complaints Handling Process.
•Close complaints with Customers and Authorities.
•Ensure process and procedures are in place.
•Country Product Surveillance activity for Medical Devices:
•Ensure effective gathering, recording, transmission to the Product Surveillance team and reporting to the competent Authorities of medical device adverse events
•Collect, follow-up, transmit all local incidents and near incidents to CTPS (Central Team Product Surveillance) using the Global tracking system and archive relevant document
•Set up and maintain an efficient Product Surveillance system in compliance with the national medical devices regulations and with Baxter standard
•Ensure appropriate contacts with other organizations such as Regulatory Affairs, Sales and Marketing etc.
•Training
•Act as the ISOTRAIN Administrator for MEA Region.
•Ensure that systems are in place and maintained.
•Train employees on quality system compliance (including new SOP’s). Ensure training records are maintained.
•Assure that Distributors and service providers are trained on Good Distribution Practices and Baxter requirements.
•Dubai Warehouse QA Responsibility:
•Ensure Compliance of Dubai Warehouse to UAE GDP and Baxter QMS requirements.
•Prepare the MOH audits and ensure satisfactory outcomes.
•GS&DP License is renewed on yearly basis and per the business need (updated to add more products).
•Ensure that QA tasks are done as per Baxter QMS requirements (Hold Management. Release Management; return management; CAPA….).
•Returned goods management
•The control of the quarantine and other segregated areas for returns and products on hold
•Product traceability, tracking and accountability, as required.
•Handling Product re-labeling process if required (protocol, processes, approval, release).
•Quality Release and Inventory Management:
•Expert of distribution related aspects of inventory management system.
•Selling Authorization.
•External Audit
•Act as Host for external bodies and baxter audit group .
•Ensure the successful outcome of inspections from Authorities or notified bodies for compliance with all applicable laws, regulations, directives, and standards.
•Set annual plan and Manage external quality audits for vendors across MEA region.
•CAPA Management:
•Manage Non-Conformity Reports and related CAPAs.
Managing qualification and validation program including routine verification and periodic validation, Calibration of all kind of instruments either related to Quality Control lab or production value streams.
•Periodic and/or initial qualification for sterile area for drug manufacturing areas including environmental control, Media fill simulation, Air system qualification, Tunnel & Autoclave Verification as well as facility qualification and area classification.
•Performance qualification (PQ), for all production machines and periodic re-qualification.
•Manage Process validation program for all products of different dosage forms e.g. sterile powder, sterile suspension, sterile liquid, semi-solid, solid, ….etc.
•Acts as Process technical risk assessment SME to identify process gaps using problem solving techniques as FMEA, gap analysis, GEMBA and Kaizen
•Owner of SOPs writing and GAP analysis for GSK Quality management system & WHO guidelines
•Acts as SME for validation program master plan e.g. cleaning & process validation and Site Validation Master Plan for the whole site.
•Change Control Process owner for all GMP changes (HR, Financial, and Quality, production, procurement, planning & regulatory).
•Managing all Quality issues in Value Streams including Solid and Oral suspension manufacturing, processing and packaging Review and approve all issued deviations and out Of Specification raised in Value Stream, ensuring that all Corrective and Preventive actions have been implemented
•Release of all produced batches after ensuring all required tests were done and results were satisfactory.
•Coach all QA inspectors for best practice and efficient handling of all Quality issues
•Ensure daily GEMBA, Inspection and In Process Control done by QA Team.
•Ensure efficient handling of Customer complaints; act as root cause analysis process owner in GSK Giza site.
•Conduct Self inspection (L1 Audit) for validation & L2 for QA and different productions departments.
•Reviewing batch records and dealing with various monographs and general chapters of USP/NF and industry standards.
•GSK sterile operations expert dealing with facility design review as well as area classification and environmental system viable and non-viable control
•Drug manufacturing researches providing Business solutions as some researches were done on Drugs to enhance its activity or improve its manufacturing capability or to comply with MOH regulations so recommended corrective actions to minimize rate of product defects.
•Inspecting, testing and measuring materials, products to ensure precise specifications marked with grade and acceptance-rejection status.
•Interpreted and classified production and quality data for manufactured drugs.
Analysis of all kind of dosage forms either as finished product or stability ones using all kinds of analytical equipment as HPLC, UV, TOC ….etc.
•Analysis of new dosage forms and new products with analytical methods verification.
•Analysis of new Active Constituents and writing of all analytical and validation reports.
•Analysis of Cleaning Validation Swaps.
•SOPs writing and GAP analysis.
•Full awareness with GLP and LIMS
•Responsible for All Chemicals Check-up and Chemical inventory in Laboratory and Ware house including Purchase orders of all solid and liquid chemicals
•Calibration of all Chemical Equipment (Balances, Karl Fisher, Dispensators, Dissolution, PH meter).
•Chemical lab analysis and HPLC integration expert (with wide knowledge in HPLC integration techniques, Stationary phase (columns) type and function, mobile phase preparation and validation).
•Participated in different project as new API(active products ingredients), products transfer projects with new manufacturing areas design.
Providing patients with all the help regarding OTC or prescription drugs dispensing. Formulation of some Drug formulas (lotions and antiseptics).
•Dealing with all distribution offices and drug companies.
•Providing patients with any required knowledge regarding the Drugs active ingredients and their adverse reactions or any interaction (drug-drug interaction or food-Drug interaction.
•Extensive Knowledge of Medicine, compounds and their dosage.
and Development specialist and Quality Control Methodology and stability specialist
•Formulation of new products of all Dosage forms.
•Awareness of all formulation pharmaceutical books as (BNF, Merck index----etc.) as well as pharmacopeia (EP, USP)
•Customizing and developing of all Analytical Validation Reports and Protocols.
•Formulation of New Methods for all Dosage Forms.
•Cleaning validation (taking production swaps and analyzing them then developing their validation reports).
•Standards check-up and Purchase as well as preparation o in house standards.
•Analysis of all stability samples, making stability protocols and stability plan.
in
courses: GSK Yellow Belt Six Sigma certified. •Quality Certified Auditor.