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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

What we offer:

• Competitive salaries
• Ability to earn additional income based on hours worked (Biweekly basis)
• Free High-Quality webinars provided by experts from around the world
• Committed to keeping our consultants in project continuity
• Referral Program
• Wellness Program
• Recognition Program (for employees only)
• Service Award Program (for employees only)
• Discount Program (for employees only)
• An administrative team that is oriented in providing excellent service that pursues satisfying the needs of our consultants.
• For our projects in the US, we cover travel/lodging/transportation expenses (employees only)

General Description:

PharmaLex Puerto Rico is seeking a experienced consultants who can provide support that specializes in the field of Quality Assurance that can provide support to a Pharmaceutical industry located in Manati, Puerto Rico.

We are currently in search of a Candidate that is well rounded in the Quality Assurance Management System mainly:

• Quality Management System (QMS) (ISO 9001:2015)
• Quality Auditing (Internal and External Audit Management)
• Quality Risk Management (e.g. FMEA)
• GMP
• Documentation and Records Control
• Nonconformance / Investigation / CAPA Management
• Complaints Management
• Change Control Management (Process, Material / Product, Equipment, Supplier, and Facility type changes)
• Supplier Management & Qualification
• Quality Control
• Data Integrity
• Quality Management Review (QMR)
• Annual Product Review (APR)
• Validation
• Training qualifications
• Batch Release / Raw Material Release
• Lean Manufacturing and Enterprise Management Systems
• Artwork Review and Approvals
• Bill of Material maintenance
• Site Master File Maintenance
• Product Recall / Mock Recall
• QMS Trend Analysis

KEY RESPONSIBILITIES AND ACTIVITIES

• Responsible for Product Release and Certificate of Analysis
• Responsible for critical systems monitoring for product release
• Responsible for Annual Product Quality Review
• Manges the electronic batch record system, laboratory system, and computerized system related to Quality Assurance as applicable to the client.
• Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
• Ensures that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.
• Responsible for quarterly execution of Management Reviews
• Responsible for the work order (manual) and rework order preparations as needed
• Responsible for the Critical Work Request processing as needed
• Conducts review and approval of the validation report (IQ, OQ, PQ) generated for the manufacturing operations, engineering utilities, and Lab equipment prior to its implementation.
• Conduct periodic reviews of project milestones and ensure compliance of action based on the project plan.
• Supports the operations/manufacturing scorecard and provides actions to ensure quality metrics are within the target goal.
• Responsible for BOM Maintenance and Annual BOM review
• Responsible for the Document Management System of the company.
• Responsible for timely review and revision of assigned plant procedures as necessary
• Performs and supports GAP Assessment
• Responsible for records control maintenance
• Responsible for Supplier qualification, maintenance, and reevaluation which includes supplier audits and supplier decommissioning
• Responsible for supplier nonconformance reporting and closure of issues
• Responsible for external audits (ISO, regulatory, corporate), responses, and closure of corrective actions
• Responsible for complaints handling and maintenance
• Responsible for Change Control maintenance and overall management of the process
• Identified as a Quality Assessor for Change Control
• Responsible for nonconformance (NCR) management and participates in the identification of a CAPA and ensures on-time implementation.
• Identified Quality Approver for NCR/CAPA and Change Control
• Responsible for Quality Risk Management
• Responsible for Quality Systems training for the plant
• Responsible for GMP/GDP training for plant employees
• Support facility compliance with the company’s quality standards, local regulatory and GMP requirements
• Identified Lead Auditor / IQA Coordinator for Internal Quality Audit (IQA) program at the plant
• Support the EMS program of the company
• Handles the product recall system in a timely manner.
• Coordinates and leads the mock recall of the company
• Performs Trend Analysis based on the critical parameters / metrics of the company.

REQUIREMENTS

• Bachelor's Degree in Sciences
• Engineering (Chemical, Mechanical, Industrial, Civil, Electrical, Electronics, Computer, Manufacturing,
• Natural Sciences (Biology, Microbiology, Chemistry, Physics, Biochemistry, and others)
• Fully Bilingual
• Previous experience within the Pharmaceutical, Biotechnology, and Medical Devices Industries
• Available to work extended hours a day and/or weekends if needed.
• Our clients require fully vaccinated resources.
• Reasonable accommodation will require valid documentation to support the request.

PharmaLex is an Equal Opportunity Employer.

Job Types: Full-time, Contract

Salary: From $25.00 per hour

Experience:

• Quality assurance: 2 years (Preferred)

Work Location: One location

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