U.S. Work authority required
PLEASE NOTE: U.S. Work authority required. Sponsorship not available
Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S. The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders.
Maintain and improve the Quality Systems within Med-Pharmex. Promote, develop and oversee compliance of company quality system. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement. The Sr. QMS Manager will report to the Director of Quality Assurance.
DUTIES AND RESPONSIBILITIES:
To manage the CAPAs, Deviations, Audits and Vendor Quality Management Programs
To promote quality culture across the site by liaising with cross functional teams
To develop and manage the QA Compliance team and provide coaching and mentoring on Quality Management Systems
To participate in internal and external audits, and support vendor quality management activities
To conduct compliance risk assessments, trend analysis and provide recommendations.
To focus on continuous improvement of processes. Update procedures and policies as needed to maintain compliance and improvement
To establish, track and present Quality Metrics to support Quality Management Review
To provide guidance for higher level decisions required for change management and deviation investigations
To manage and plan required internal annual audits and other audits as needed and assigned.
Review and/or conduct thorough investigations and act as the Investigation Team Lead for Incidents/Deviations, OOS Investigations, Laboratory Events and Product Complaint Investigations as required following appropriate company procedures.
To supply feedback to the Head of Quality and SLT on any trends and serious quality issues or non-compliances that are detected by QA staff whilst carrying out duties for GMP and GDP activities
To liaise with auditors to ensure that the CAPAs resulting from audits associated with the assigned programs and studies are allocated a CAPA owner and closed out appropriately and in a timely manner
To author, review and/or authorize Standard Operating Procedures (SOPs)
To ensure adequate QA resources are available to deliver the agreed business targets
To proactively influence management regarding the adoption of standards to improve quality, efficiency and compliance.
Ensure all investigations are completed in a timely manner to support product release and regulatory compliance
Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools
Assist during regulatory inspections or other audits, as required
Maintain knowledge of current regulatory requirements pertaining to pharmaceutical products
Maintain effective communication and partnership with all departments across the organization
Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations.
Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures.
Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management.
Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested.
Other duties may be assigned by the Director of QA.
Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred.
Minimum of five (5) years of experience working in a Pharmaceutical GMP environment.
Minimum of five (5) years of experience in a QA and/or QS role in a pharmaceutical manufacturing environment.
Lean, Six Sigma and cGMP experience preferred.
Proficiency in Microsoft Office particularly in Excel, PowerPoint, and Word. LIMS systems and ComplianceWire experience is a plus.
Demonstrates a “can do” approach
Self-motivated, with the ability to work proactively using own initiative
First class organizational skills and the ability to multitask.
Must have Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team
Excellent attention to detail, with the ability to work accurately in a busy and demanding environment
Demonstrates time management skills
Using logic and reasoning to identify solutions to problems
Ability to lead, motivate, coach, and teach others
Demonstrated ability in working independently and as part of a team.
Must be able to work in a cross-functional environment interacting with other internal departments and external vendors.
Must be able to communicate technical, scientific, and regulatory information, both written and verbally.
Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance.
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
Med-Pharmex is an equal opportunity employer and prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender (including gender identity and gender expression), medical condition, genetic information, marital status, national origin, mental and physical disability, military and veteran status, or any other characteristic protected by law.
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