Quality Systems Specialist

Quality Systems Specialist

Department: Quality Plant Head

Location: Monroe, NC

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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

POSITION SUMMARY:

Under the direction of the Director/Manager, Quality Systems, the Quality Systems Specialist is responsible for managing the elements of the Quality Systems including, but not limited to: Change Controls, Quality Events, Deviations, Corrective and Preventative actions, QMR, Risk Management. This individual works closely with cross-functional teams at the site and abroad. This individual will routinely report on quality system and business process performance; proactively identifying, providing guidance and implementing process and system improvements to resolve complex issues in a timely manner.

JOB RESPONSIBILITIES:

Provide support in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

• Ensures investigations are logged, triaged, investigated, and resolved according to established deadlines, company and regulatory requirements.

• Coordinates with cross-functional teams for testing of reserve or retain samples for investigation purposes, where applicable.

• Coordinates the reviews of relevant records, (e.g. batch records, quality control data, quality investigations, etc.)

• Conducts root cause analysis in order to facilitate and initiate corrective and preventative actions wherever needed.

• Tracks quality system metrics and creates detailed trend analysis reports.

• Performs analysis of data, trending and provides metrics for Quality Systems, as required.

• Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.

• Coordinates evaluation of implementation for Global Policies and Procedures

• Evaluates and assists in the implementation of new changes for the site.

• Supports implementation of projects that improve site Quality and/or efficiency.

• Assess changes in terms of their impact to CGMP and using Risk Management tools.

• Prepares and compiles 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.

• Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.

• Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, Deviations

• Coordinate and collect information from departments for performing QMR and annual product review

• Establish, revise, review and continuously improve procedures for all Quality Systems.

• Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.

Education:

• Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent

Experience:

• Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills:

• Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.

• Must be proactive, results-oriented with a strong attention to detail and strong 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 ability to interact with all levels of personnel in a professional manner.

• Intermediate Excel and/or Minitab skills are required including, but not limited to: spreadsheet manipulation, charting, and analysis tools.

• Ability to work independently, or within a team structure, and on multiple projects, with flexibility 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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