Quality Systems Specialist

Quality Systems Specialist

Department : Data Management

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 :

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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