DUTIES & RESPONSIBILITIES
This position is responsible for the online review and Quality Events investigations associated to all manufacturing and packaging process ,batch records and; approve from Quality standpoint process related documentation for assuring that manufacturing activities are carried out within the framework of corporate/governmental policies and regulations (cGMP’s). The position will have the Subject Matter Expert (SME) role from the Quality perspective to provide guidance and coaching to different areas / department The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices, required by the job function.. Reviews and approves the executed batch records pertaining to the preparation, formulation, granulation, compressing, coating and printing or any additional stage (e.g. inspection) of the final dosage form of all products manufactured in the Humacao site.2. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough investigations.3. Opens notice of event (NOE) in the Trackwise system for any detected incident, deviation or documentation error during the batch record review process. 4. Assures that Quality Events (QE) are completed within the time frame provided in site procedure. If time extension is required, assure timely submission of required documentation.5. Evaluates and approves investigations and CAPA’s for returned goods, damaged goods, process deviations and laboratory investigations.6. Reviews Quality Events Reports performed by operational areas to assure that Root Cause was identified, adequacy of correctives and preventives actions taken and proposed, report redaction and format is adequate, clear and in compliance with BMS procedure.7. Recommends material or product disposition, if required.8. Evaluates specification, recommends and submits changes when necessary to the specifications committee. Provides advice and service to all operating departments as to assure compliance with cGMP’s and other regulations. (This includes frequent feedback on performance regarding deviations, rejections, complaints, outstanding commitments, trends, etc.).10. Conducts and documents GMP and/or SOP’s training as required.11. Reconciles the materials used for the manufacturing of each product stages using the SAP transaction MB56 and report any discrepancy.12. Evaluates inventory frequently to drive closure of pending items to assure timely disposition.13. Assists in the Supplier Qualification/Certification program.14. Performs readiness exercises for government inspections.15. Assists in the material / Lots disposition when required.16. Maintains actively communication with other site Quality and Operational areas to keep lot status posts and drive timely resolution of quality issues.17. Participates actively in coordination with the QA & Compliance Department during Regulatory inspections and / or during internal company audits.18. Writes, reviews and implements epartmental procedures to assure update with current practices or GMP trends.19. Reviews and provides Quality Approval to operational areas procedures and Manufacturing Master Documents assuring compliance with current practices and/or GMP trends.20. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials.21. Suggests improvements in the working area related to documentation design and flow to the process area22. Generates Rejection Notices and rejection labels. 24. Executes periodic activities related to SAP such as : a) Cancelation of open inspection lots created for re-assay (reexamination) – on a weekly basis. b) Communicates to Master Scheduler of any QC initiated movement of material to blocked status in no later than 48 hours after decision 23. Manages open inspection lots in SAP.24. Escalates to management relevant situations that may impact product disposition and may cause product shortage in the market. 25. Performs any special duties assigned by the QA/PD Associate Director.
MINIMUM REQUIREMENTS
Bachelor in Science (Microbiology, Chemistry, and General Sciences), Engineering or Pharmacy. * Five (5) years of experience in Pharmaceutical Manufacturing Industry with exposure to Quality and Manufacturing field. * Broad knowledge on Quality Systems such as Change Control, Investigations and CAPA’s. * Fully Bilingual (Spanish/English).
Ability to communicate effectively with wide range of personnel, written and verbal. * Broad knowledge of relevant governmental regulations, cGMPs and guidelines. * Solid technical writing skills related to investigation reports
Ability to create / organize cGMP systems procedures based on regulatory / compliance requirements
Self-motivated, creative and team work oriented. * Good organizing and planning skills. * Computer skills (Require to use computerized systems). * Able to work under pressure and availability to work at any time needed. * Available to work rotating shifts, extra hours and on weekends.
Job Types: Full-time, Temporary
Experience:
Quality Assurance: 3 years (Preferred)
