Quality Assurance Pharmacist
Abbott Laboratories
Total years of experience :12 years, 4 Months
- Ensure Implementation, maintenance and continuous improvement of efficient Pharmaceutical quality system according to applicable local regulatory requirement and relevant global GMP/ GDP requirements.
- Act as Primary contact for local health authorities and own relationship/ communication with health authority in the matter of GDP and GSP.
- Maintain GDP/GSP license and apply for Import and export permit for required shipments from Health Authority.
- To be involved in product disposition decision to Quarantine/Rejected and dispose of returned, damaged, recalled or falsified product.
- Initiate the reporting, investigating and monitoring of all product related customer complaints, quality defects and adverse effects as per quality system.
- Monitor Non-conformances and implementation, execution and administration of CAPA’s according to quality system requirements.
- Participating in internal audits (self-inspections) and supports external and regulatory audits.
- Tracking and assisting in the closure of Internal and External Audit and make sure effective implementation of CAPA
- Implement and monitor good documentation practices and controls the changes as per quality system requirements.
- Develop and maintain quality documents such as Quality Manual, guidelines, SOPs check lists etc.,
- Apply risk management, change control and impact assessment in all quality related decisions.
- Develop and implement Quality Training Plan and provide Quality specific training in GMP/GDP, complaint handling, data integrity etc.
- Maintain and control the processes of supplying samples of pharmaceutical products and make sure the traceability of samples.
- Support, implement and control Field actions and product Recalls as required.
- Advise Supply Chain, Marketing etc in quality related matters.
- Is accountable for all quality KPIs for the market and leads management review.
- Participates supplier qualification process and ensure periodic verification of compliance.
- As an active member of Global QA Community, contribute to develop and strengthen global quality management systems, and provide flexible support to business both at the country level and global level.
- Make sure the compliance on promotional materials and product artworks according to local regulatory and GMP/GDP requirements
Customer Service Activities:
• Act as primary contact to customers and vendors.
• Responsible for reviewing the sales forecasts and order processing of private and tender markets for all vendors.
• Work with customer, logistics & warehouse to ensure timely delivery taking into account local requirements.
• Organize Inspection of the shipment when required (Letter of Credit) and follow up on the Inspection Certificate.
• Handle Letter of Credit from receiving till documents sent to the bank including collecting all necessary documents and get them legalized by the Destination Country Embassy.
• Check all orders related data (codes, prices, order status reports...).
• Maintain Customer related data in the appropriate systems.
• Verification of credit limits and export license and ensure we are processing as per Trade Compliance Guidelines.
• Adjustment and maintenance of prices in the system.
• Handle import & export shipments and inventory.
• Collaborate with the central team and monitor the shipping details.
• Generate monthly sales report, update forecast.
• Complete the weekly Operational Report with indication of each line for all open orders as well as indicating reasons for the BO and Get Well Dates.
• Complete the Monthly Order Fulfillment Report and identify rooms for improvements.
Inventory Management:
• Low cover management.
• Low cover control and warnings.
• Follow up utilizing Back Order comments.
• Pipeline visibility: Timely and proactively transmit full pipeline info on back order, low cover products to Customers and Marketing, inform on product replacement, substitution and obsolescence and support allocation plan.
• Slow Moving/Excess Inventory Management.
• Ensure Management of local MRB coordination and execution to agreed requirements.
• Consignment inventory and discards follow up.
Operations:
• Work closely with Finance Community to align Logistics & Financial Forecast by identifying gaps/opportunities/assumptions.
• Manage order from receipt to delivery with the different stakeholders, Product Planner, Finance, Logistic.
• Provide weekly accurate feedback on the Order Book with expected shipment date and related comments.
• Ensure delivery on time by following closely products productions with dedicated planners.
• Create Monthly Report and conduct/or participate in country S&OP.
• Identify process gaps & solutions to enhance results.
• Identify Action Items to improve monthly indicators.
• Maintain and monitor customer collaboration activities / collaborative forecast.
• Monitors activities that will impact demand signal & updates forecast accordingly.
Support Activities:
• Data Integrity: check and correct data accuracy issues with regard to master files.
• Code creation proposal and follow up with Manufacturing, RA, Finance and Business.
• Support daily customer service processes (control of consignment, back orders, low cover).
• Support Product Conversions: Ensure new forecasting & order management processes in place as conversions take place and monitor plan locally.
• Full participation and support of Supply Chain Planning projects.
• Follow-up releases and labeling priorities with QC.
• Maintain country profile / SLA for the country.