Summary:Accountable for monitoring and assuring the Retains Program compliance with established procedures, guidelines, policies and regulatory requirements. This includes the accountability of the Retains SOPs, Retains Sampling, Retains Storage and Testing, according to established procedures. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.Responsibilities:Develops Retains instructions according to established procedures and/or Regulatory commitments.Evaluates and recommends Drug Product lots that have to be placed on the retains program according to internal / corporate procedures and regulatory agencies, for different markets.Evaluates Retains data and determines whether an adverse trend exists that could merit management notification or actions such as field Alert or BPDR or Product Recall.Coordinates the retain samples collection, storage and testing at BMS-Manatí facility, including external coordination with other BMS facilities, and contractor facilities when needed.Assures that the retain samples are performed following the internal procedures.Provides guidance of retains requirements to support special activities such as but not limited to: new product launches; changes in manufacturing processes; changes in packaging components.Performs and coordinate the retain sample collection process to support special activities.Performs and coordinate the retain samples monthly schedule and ensure the adherence with timeline defined in procedure.Performs and/or supports retains investigations in the event of Out of Specification (OOS) according to QA - S 073 procedure and conducts retain investigations related to procedures and/or protocol deviations.Supports complaints investigations by doing the appropriate retains testing as required by the investigation processDevelops and implements procedures to assure retains Program is harmonized with current practices, cGMP's, policies and directives.Participates in the change control meetings to evaluate proposed changes related to the retain program.Performs as the key contact person for the retain Program issues.Performs data gathering got from Annual Product Quality Report (APQR) for the retain program.Maintains accurate and complete records of all lots in the retain Program.Prepares retain monthly metrics.Performs retain sample disposal periodically.Performs chamber inventory according to the established procedures.Serves as a resource to other site departments and BMS groups providing any data related to the Retain program when requested.Knowledge/Skill:Bachelor Degree in Sciences (Chemistry, Biology or Engineering)Five (5) years of experience in the pharmaceutical industryStrong knowledge of Retain Program (end to end view of retain quality attributes thru shelf life)Knowledge of statistical toolsExperience performing and conducting product quality investigationsProficiency in oral and written communications skills in both Spanish and English Knowledge and working experience with computers and appropriate software packages (e.g., MS Word, MS Excel, Empower, LIMS, etc.)Ability to create and review SOP's and / or operating instructionsAbility to perform multiple tasks simultaneously in a changing environmentExcellent organizational skills to plan and prioritize workloadKnowledge of root cause analysis and investigation processesWilling to work irregular hours, rotative shifts, weekends and holidays, when necessary
Ciudad: manati
