Overview
FSQA Tech I – Receiving Nights Jobs in Conway, AR at Westrock Coffee
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 – Site Investigations &Quality Systems, the Senior Manager QA Systems and Compliance is responsible for managing the investigation and resolution of Quality Systems notifications including, but not limited to: Quality Events, Investigations, Change Controls, Deviations, CAPA. This position is also responsible for managing the electronic Quality Management Systems, process improvements and training associated with Quality Management Review (QMR), Investigation, Change Control, CAPA, Quality Risk Management (QRM), Annual Product Review (APR) and coordinate the implementation of global policies and procedures at the site. 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:
Ensures departures from procedures or processes are triaged and if determined a quality events, logged, 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.).
Provides training and conducts root cause analysis in order to facilitate and initiate corrective and preventative actions wherever needed.
Review and coordinate with different stakeholders to complete investigations timely and ensure CAPA actions implemented within timeline.
Train and support qualification of Investigators and continuous learning opportunities.
Assist in identification and implementation of continuous improvement initiatives for investigations qualification process
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.
Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate or vendor audits and audit readiness related activities.
Support internal and external/regulatory audits / inspections when required.
Coordinate and conduct training related to QMS modules for the site timeline.
Organize and enhance metric standardization to support site QMR
Coordinate implementation of global policies and procedures at the site
Evaluate, review and assist 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.
Ensure support for hosting CCRB and capturing associated meeting minutes sent to attendees as needed
Tracks metrics and creates detailed trend analysis reports.
Prepares and compiles the required data to support the APQR submission for the products manufactured on site.
KNOWLEDGE, SKILLS AND ABILITIES:
Bachelor of Science (BS) / Bachelor of Arts (BA) on 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.
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Title: FSQA Tech I – Receiving Nights
Company: Westrock Coffee
Location: Conway, AR
