Quality Assurance Scientist - RCM Technologies (Puerto Rico)
Reference # :19-00051Title :Quality Assurance ScientistLocation :Manati, PRPosition Type :Full Time/ContractExperience Level :6 YearsStart Date / End Date :02/04/2019 / 02/04/2020 Description
Quality Assurance Scientist experience and expertise requirementsThe resources must meet the following minimum requirements in order to be considered:
+ 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 laboratory instruments operations and background in pharmaceutical products manufacturing environment.
+ Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment, Data Mapping etc), EU regulations and the ability to interpret and apply them for intended use
+ Knowledge with network communications protocol (i.e. TCP/IP)
+ Acquainted with GAMP5 methodology for validations.
+ Good skills revising validation/commissioning, and technical documentation in English and using MS Office applications.
+ Fully bilingual (Spanish/English) communication skills, both written and verbal.
+ Self-motivated, creative and team work oriented
+ Technical and scientific capability to make firm decisions and recommendations
+ Excellent interpersonal skills and the ability to interact with people at all levels
+ Effective communication Skills
+ Sense of urgency and analytical thinking
+ Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) 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
The resources will support the Quality Assurance Area during the implementation of the laboratory Instruments 2018 execution project. The equipment/systems, and quantities to be validated as part of this project are listed as follows: The scope of the quality services deliverables are as follows:
+ Evaluates documentation compliance for all manufacturing and support areas such as CR's, SOP's, BR's, BOM's, WPP's, URS, qualification and validation Protocols, validation plans according with government regulations and Client Policies.
+ Reviews and approves the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing/laboratory equipment, processes, and systems with respective reports.
+ Reviews and approves the Process/Laboratory Performance qualification protocols, Traceability Matrix document, and Validations reports among others.
+ Reviews and approves all equipment, utilities, facilities, process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology laboratory, and Annual Product Quality Review (APQR's) elements.
+ Reviews and approves procedures related to process, products, utilities, and laboratories, and ensures compliance of all procedures (SOP's-Operational and/or Administrative) to avoid potential regulatory and compliance issues.
+ Supports, review and approves actively the investigation process occurred in manufacturing, warehouse, calibration, analytical and microbiology laboratory, facilities and utilities areas related to process, products, utilities among others providing coaching from Quality perspective. 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.
+ 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.
+ Manages audit observation, investigations, change control and CAPAs records in Trackwise on timely manner.
+ Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required.
+ Review and approved the Risk Assessment (RA), Data Integrity Assessment (DI), Data Mapping/Data Flow, and Audit Trail Review Applicability.
+ Reviews and approves the Commissioning Packages for the electric and/or vacuum system infrastructure as applicable.
+ Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
+ Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings. Ensures there are effective systems for the maintenance and calibration of equipment and approves of calibration requests.
+ 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.
+ Verifies consistency with other site procedures and/or specifications.
+ Reviews and approves Corrective and Preventive actions (CAPA's)