Heidy Lorena Correa Hernandez

• Responsible for designing, implementing and managing the Quality Management System of the manufacturing and supply chain processes, to consistently ensure compliance with Good Manufacturing Practices, storage and distribution.

• Develop and implement processes and procedures at the manufacturing site to achieve full compliance with global policies and standards, and regulatory requirements for the markets where products where distributed (US included).

• Propose, implement and participate in changes, evaluations, remediation plans, and follow-up for Continuous Process Improvement and operational excellence.

• Enhanced product quality by developing and implementing robust quality management systems such as: Change control management, internal and external audit programs, suppliers management, CMO management, training program, risk management and documentation management.

Key achievement:

• Contributed significantly to successful FDA inspection of the manufacturing site.

• Responsible for Quality assurance at the manufacturing site (solids, liquids non-sterile, and liquids sterile pharmaceutical forms), including product release, quality inspection on production lines, batch record review, deviation and CAPA management, complaints management, quality at warehousing.
• Management of quality topics with Third parties manufacturing (customers).
• Reduced defects in products by conducting thorough inspections and identifying areas for improvement at manufacturing lines.
• Collaborated with cross-functional teams to identify root causes of product issues, leading to define, implement and follow-up the proper action plans.
• Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
• Investigated customer complaints and performed corrective actions to resolve quality issues.
• Assessed product quality by monitoring quality assurance metrics, reports and dashboards.

• Develop and implement strategy to put in place an effective, sustainable and reliable Stability process at the manufacturing site.
• Identify stability gaps and determine and implement an action plan to be in compliant with local, global and corporate guidelines.

• Responsible for managing the Quality Department covering all aspects of GMP/GDP related to the business
• Led regulatory inspections preparation assuring readiness, flawless execution, and proper response (CAPA plan) to the Health authority or interested party
• Monitored the effectiveness of the Pharmaceutical Quality System, through monthly reports, KPIs, and annual quality reviews
• Fostered a culture of quality awareness among local management members
• Deployed all quality activities aiming to ensure compliance with the technical and regulatory requirements for medicines and medical devices
• Drove activities related to the Quality Management System including handling of Deviations, Change control, complaints, CAPAs, quality audits, risk management process
• Implemented Corporate quality standards, applicable local GMP and GDP regulations into local procedures and policies
• Ensured life cycle management of technical product information and documentation
• Assessed proposed improvement to manufacturing processes and analytical tests, to determine potential regulatory or quality impact
• Drive all activities aiming to qualify all GMP relevant suppliers, including quality audits
• Managed the finished product release to the market
• Decided and coordinated collecting/ recalling product from the market
• Managed and solved technical, quality and compliance issues with the local Contract manufacturing organization (CMO)
• Act as liaison between QA and other functional areas, and represent QA in cross-functional team meetings

• Responsible for managing several quality systems such as: change control, deviation, complaints and CAPA, including thorough root cause investigations followed by the definition of inclusive action plans
• Drafted and managed the documentation system (policies, procedures, technical documents)
• Planned and developed the annual GMP audit plan (self, internal and external audits), followed by the applicable CAPA plan
• Managed of the qualification process of relevant suppliers GxP
• Supported foreign market´s regulatory requirements, aiming to maintain marketing authorizations updated
• High expertise in handling quality alerts and product recall situations
• Implemented a risk management approach for the quality issues
• Prepared, followed up, and periodic reporting of quality KPIs
• Managed Quality and technical issues for the local CMO (Contract manufactured organization)
• Drafted monthly quality reports, and annual quality management review report
• Planned and follow up on the annual product stability Program
• Implementation of Good distribution practices pillars among the distribution chain
• Experience in finished product release to the market, return management, and rejections

Key achievements

• Redesign and rebuild the Quality system of the subsidiary after a business model change
• Sustainable improvement on the subsidiary Quality KPIs, by fostering a quality culture the organization (overall Quality index went from 45% to ≥95%)
• Putting in place procedures, KPIs and communication channels with the CMO aiming to guarantee the quality of outsourced medicines

• Proposed and deployed policies and procedures, to ensure compliance with legal regulations related to pharmacies operation and business processes
• Drafted and implemented of standard procedures to comply with the good elaboration practices (GMP) for sterile mixes
• Defined and implemented practices and procedures for proper management of controlled drugs
• Advice and support in the technical, scientific and quality criteria in the supply chain processes

• Responsible for managing the system for control, updating, reviewing, approval, and archiving of the technical documents required at the manufacturing site
• Guarantee regulatory compliance of operational documents vs. marketing authorization
• Reviewed, approved and controlled company procedures
• Drafted, followed up, and periodic reporting of quality KPIs to headquarters and internal parties
• Prepared and submitted dossier packages for obtaining and renewing Marketing authorizations of medicines in Colombia and abroad
• Drafted the Site master file of the company
• Conducted internal GMP audits and self-inspections, supplier audits and CMO audits
• Drive root cause investigation of deviations and complaints, proposed and follow up to CAPA plan
• Managed and improved the Change control system
• Supported and contributed to new product introduction
• Provided support during mock recall and product recall
• Prepared and attended regulatory inspections (Colombia, Argentina, Brazil, England, Australia) and third-party customers

Key achievements

• Lead the design and implementation of quality management tool for change control, deviations, CAPA, complaints, indicators, audits and training management.
• Successful implementation and deployment of SAP at the manufacturing site as QM Key user in Merck (2008) and Altea Farmaceutica (2012)
• Design and implementation of Lean / Six sigma projects at manufacturing and quality areas

• Performed Quality Control analysis of finished products (medicines) and raw materials, using analytical methodologies such as: volumetry, HPLC, UV spectrophotometry, potentiometry
• Managed and maintained of standard substances
• Provided support in validation of analytical methodologies
• Updated of QC testing procedures and specifications according to pharmacopoeias (USP, EP)
• Performed equipment calibration to maintain accuracy in testing procedures
• Processed and managed OOS results

• Conducted physicochemical tests of sterile products using analytical methods such as: volumetry, potentiometry and atomic absorption spectrometry.
• Conducted QC analysis of raw materials and sterile water for injection
• Provided suppor for development of product stability studies.
• Performed microbiological testing of sterile products and water: pyrogen test, sterility, sowing.

• Designed and executed manufacturing processes and cleaning processes validations
• Executed equipment qualification (IQ, OQ, PQ)
• Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems