Über die Tätigkeit

  • Ability to identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
  • Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.
  • Provides review of production specific Deviations / Investigations, CAPAs, Change Controls
  • Assist in generating procedures related to Manufacturing QA functions / activities
  • Observe and identify conformance to defined procedures and batch specific steps within the aseptic areas
  • Periodically review records to verify that quality standards for each drug product is met
  • Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
  • Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
  • Responsible to maintain all testing equipment in compliance, calibration and certification.
  • Assists in developing policies and procedures related to QA
  • Promptly communicates with Operations regarding complaints, product issues/variances.
  • Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
  • Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.
  • Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantly
  • Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
  • Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
  • Conduct and report the findings of internal investigations of compliance issues.

Ihr Profil

  • BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
  • Minimum 2 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field.
  • Ability to effectively communicate
  • Decision making ability
  • Oversight of operations with a focus on Sterility Assurance
  • Ability to multi-task and prioritize
  • Experience supporting compliance in a quality/compliance/ function /applicable compliance field preferred
  • Knowledge of QMS and CAPA related tools or systems is preferred.
  • Environmental, monitoring or audit experience is an asset
  • Experience with inspections and inspection readiness activities preferred.
  • Personal leadership with demonstrated competency interfacing with department leads preferred.
  • Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
  • Excellent communication skills.
  • Listening, interpreting and summarizing information
  • Clear and concise verbal communication
  • Professional and concise written communications –exceptional attention to detail
  • Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
  • Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
  • Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
  • Strong project management skills: MS Word, Excel, PowerPoint,
  • Flexible and able to adapt to company growth and evolving responsibilities.

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