DUTIES & RESPONSIBILITITES
To assure that the manufacturing operations (Parenteral and/ or Oral Solid Dosage) are performed in compliance with domestic and international cGMP regulations, and Client's policies and procedures. To provide scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, protocols, procedures, qualification and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. Comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.1. Interfaces directly with manufacturing operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.2. Leads and participates in the critical review of all documents associated with the manufacturing operations, release, packaging and relevant activities in the operations areas. Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.4. Provides key technical guidance and oversight to manufacturing operations areas (OSD and / or Parenteral product) such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure the appropriate cGMPs are in place through weekly operations audits.5. Ensures compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues.6. Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.7. Supports actively the investigation process occurred in manufacturing area (OSD and Parenteral products) and warehouse, Microbiology laboratory, facilities and utilities providing coaching from Quality perspective.8. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.9. Supports risk analysis process when a quality event has happened that cannot be solved immediately. This assessment needs to be completed to continue or prior to resumption of manufacturing process.10. Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed. 11. Manages audit observation, investigations, change control and CAPAs records in Trackwise on timely manner. 12. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.13. Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required.14. Evaluates documentation compliance for all manufacturing and support areas such as CR’s, SOP’s, BR’s, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and Client's Policies.15. Provides support to the area QA Leader during the budget preparation activities.16. Evaluates department performance indicators and develop the appropriate corrective actions if needed17. Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).18. Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.19. Performs trend analysis to provide recommendations in order to improve the process and /or the product quality.20. Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established. 21. Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.22. Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.23. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.24. Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements.25. Approves or reject procedures impacting drug products, raw material or packaging components.26. Verifies compliance with Client's Policies and Guidelines.27. Participates as quality representative or liaison in site projects28. Performs pre-operational review form approval in the manufacturing and packaging area.29. Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.30. Verifies consistency with other site procedures and/or specifications.31. Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.32. Approves Corrective and Preventive actions (CAPA’s).
33. Approves or reject specifications impacting drug products, raw material or packaging components.34. Ensures there are effective systems for the maintenance and calibration of equipments and approves of calibration requests.35. Ensures the designation and monitoring of storage conditions for quarantine materials and products.36. Reviews and approves procedures related to process, products, utilities, and laboratories.
• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology).• Six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry.
• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing.• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use. • Fully bilingual (Spanish/English) communication skills, both written and verbal.• Self-motivated, creative and team work oriented.• Excellent interpersonal skills and the ability to interact with people at all levels.• Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP.• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)• Willing to work irregular hours, rotative shifts, weekends and holidays when needed.