Quality Systems Investigations Specialist

4 weeks ago

Monroe, North Carolina, United States Glenmark Pharmaceuticals USA Full time
Job Title: Quality Systems Investigations Specialist

Glenmark Pharmaceuticals Inc., USA, is a leading player in the discovery of new molecules-both New Chemical Entities (NCEs) and New Biological Entities (NBEs). Our fast-growing and robust US generics business plans to move into the innovative market. We market APIs to regulated and semi-regulated countries.

Job Summary:

Under the direction of the Director/Manager of Quality Systems, the Quality Systems Investigations Specialist leads the site investigation, CAPA, change control, risk management, and management review processes. The Quality Systems Specialist will actively engage cross-functional teams, site, and corporate management to lead Quality Events, Deviations, Corrective and Preventative Actions, and Investigations to closure.

Key Responsibilities:
  • Ensure investigations are logged, triaged, investigated, and resolved according to established deadlines and company and regulatory requirements.
  • Coordinate with cross-functional teams for testing of reserved or retained samples for investigation purposes, where applicable.
  • Coordinate the reviews of relevant records (e.g., batch records, quality control data, quality investigations, etc.).
  • Conduct root cause analysis to facilitate and initiate corrective and preventative actions wherever needed.
  • Perform analysis of data, trending, and provide metrics for Quality Systems, as required.
  • Ensure Quality Systems comply with CGMPs and internal/external regulations and procedures.
  • Coordinate evaluation of implementation for Global Policies and Procedures.
  • Supports implementation of projects that improve site Quality and efficiency.
  • Assess changes in terms of their impact on CGMP and use risk management tools.
  • Prepare and compile the required data to support the APR submission for the products manufactured on-site.
  • Provide support to collect and prepare QMR board presentation and associated documentation.
  • Complete and maintain certified investigator training requirements to ensure SIT representation for identified area(s).
  • Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPAs.
  • Participate in continuous improvement initiatives for investigations and associated investigation certification process.
  • Work with CIT team as needed for Major and Critical Investigations to align with corporate guidelines.
  • Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, and Deviations.
  • Trains and guides individuals on how to process Quality Events, Deviations, and CAPAs in an effective and efficient way.
  • Coordinate and collect information from departments for performing QMR and annual product review.
  • Holds cross-functional meetings to discuss root cause analysis of investigations and quality events.
  • Establish, revise, review, and continuously improve procedures for all Quality Systems.
  • Establish key performance indicators (KPIs) for functional areas and ensure that systems operate within the target.
  • Track and trend events/deviations.
  • Develop/author quality SOPs and related documents as needed.
  • Perform routine audits of processes and gap analysis as needed.
  • Perform quality review of documentation and processes.
  • Provide trend reports of quality events.
  • Ability to convince individuals of the minimum requirements for investigations.
  • Excellent Interpersonal skills.
  • Communication Proficiency.
  • Decision Making.
  • Detail Oriented.
  • Problem Solving/Analysis.
  • Quality.
  • Results Driven.
  • Technical Capacity.
Requirements:
  • Bachelor of Science (BS) / Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent.
  • Minimum 5 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry or a combination of education and experience.
  • Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) related to the pharmaceutical industry.
  • Must be proactive and results-oriented with a strong attention to detail and time management skills.
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced, critical work environment.
  • Ability to analyze details and perform structured decision-making on a daily basis.
  • Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English.
  • Strong interpersonal skills with the ability to interact professionally with all personnel levels.
  • Intermediate Excel and Minitab skills are required, including, but not limited to, spreadsheet manipulation, charting, and analysis tools.
  • The ability to work independently or within a team structure on multiple projects and be flexible enough to adapt to changing priorities is required.
  • Self-starter with the ability to work independently with minimum supervision and use good judgment or as a contributing member of a team.
  • Any quality or lean/Six Sigma certifications are a plus.

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