Senior Quality Assurance Plant Support Specialist
About the Job
This position is responsible as a Site Subject Matter Expert (SME) to provide Shop floor quality perspective review and approval, of in line/off line manufacturing batch records associated to all manufacturing and packaging process and to directly overlook manufacturing activities to assure that these are performed within the framework of corporate/governmental policies and regulations (cGMP’s). Also responsible for plant wide review and approval of Quality Events investigations associated to site operations and Master Documents such as qualification/ validation protocols/reports. The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices, required by the job function. Oversees shop floor manufacturing activities by being present during manufacturing activities 80 % of time in order to provide SME quality guidance and/or approval to ensure full compliance with cGMP’s and other regulations. 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. Identifies improvements in the working area related to documentation design and flow to the process area. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough investigations. Assures that Site Quality Events (QE) are completed within the time frame provided in site procedure. If time extension is required, assure timely submission of required documentation. Evaluates and approves investigations and CAPA’s for returned goods, damaged goods, process deviations and laboratory investigations. 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. Reviews and approves completed CAPAs. 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.). Conducts and documents GMP and/or SOP’s training as required. Perform site Walkthrough following applicable procedure. Support readiness exercises for regulatory inspections. Assists in the material / Lots disposition when required. Maintains actively communication with other site Quality and Operational areas to keep lot status posts and drive timely resolution of quality issues. Participates actively in coordination with the QA & Compliance Department during Regulatory inspections and / or during internal company audits. Writes, reviews and implements departmental procedures to assure update with current practices or GMP trends. Reviews and provides Quality Approval to operational areas procedures and Manufacturing Master Documents assuring compliance with current practices and/or GMP trends. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials. Suggests improvements in the working area related to documentation design and flow to the process area. Generates Rejection Notices and rejection labels. Escalates to management relevant situations that may impact product disposition and may cause product shortage in the market. Reviews and approves validation/qualification protocols and final reports, such as, but not limited to\: Equipment Qualification, Process Validation, Computer Validation, Method Transfer & Validation, Periodic Reviews. Provides quality perspective and approval for change controls. Performs any special duties assigned by the Senior Manager, BU Quality Assurance Operations or the Associate Director, Quality Assurance.Qualification:
Bachelor’s degree 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.