QUALITY SYSTEMS - INVESTIGATIONS SPECIALIST
Company: Glenmark Pharmaceuticals USA
Location: Monroe
Posted on: October 17, 2024
Job Description:
Glenmark Pharmaceuticals Inc., USA, is a subsidiary of Glenmark
Pharmaceuticals Ltd., a leading player in the discovery of new
molecules-both New Chemical Entities (NCEs) and New Biological
Entities (NBEs). Eight molecules are 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. The USA subsidiary also markets APIs to
regulated and semi-regulated countries.
POSITION 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 the cross-functional teams, site and corporate management to
lead Quality Events, Deviations, Corrective and Preventative
Actions, and Investigations to closure. The individual will
facilitate the Investigation and CAPA Review Boards and support the
site Change Controls, QMR, and Risk Management processes, among
others. This individual assists in monitoring quality system health
and business process performance via metrics and trending,
proactively identifying, providing guidance, and implementing
process and system improvements to resolve complex issues promptly
ensuring a smooth and efficient work process.
JOB RESPONSIBILITIES:
- Ensures investigations are logged, triaged, investigated, and
resolved according to established deadlines and company and
regulatory requirements.
- Coordinates with cross-functional teams for testing of reserved
or retained 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 to facilitate and initiate
corrective and preventative actions wherever needed.
- Performs analysis of data, trending, and provides metrics for
Quality Systems, as required.
- Ensure Quality Systems comply with CGMPs and internal/external
regulations and procedures.
- Coordinates 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.
- 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.
- 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 Education:
Bachelor of Science (BS) / Bachelor of Arts (BA) in Science,
Engineering, Pharmaceutical Sciences, or equivalent
Experience:
Minimum 5 years in Quality Assurance in the pharmaceutical,
biopharmaceutical, or medical device industry or a combination of
education and experience.
Knowledge and Skill:
- 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.
Keywords: Glenmark Pharmaceuticals USA, Charlotte , QUALITY SYSTEMS - INVESTIGATIONS SPECIALIST, Other , Monroe, North Carolina
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