Principal Specialist, QA Investigation

Job Title:      Principal Specialist, QA 

Location:      Columbus, OH

Job Type:     Full time

Req ID:          7820

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Principal Specialist, QA Investigations to join our team.  In this role, you will be responsible for ensuring quality and compliance to regulations with respect to investigations i.e., generation, review and approval while assuring appropriate Corrective Action-Preventative Action (“CAPA”) and any further action required for the product is identified.  To ensure quality and compliance in the approval of quality reports (including APR, PQR, etc. for commercial product manufactured and/or packaged at the site.  Partner with Operations to address quality issues determined from complaints or APRs.

 

Key Responsibilities:

• Reviews and approves investigations, assuring the investigation is sufficient and that the corrective and preventative actions are appropriately identified. 
• Approve Quality reports: as examples APRs and PQRs.  Assures that the information regarding historical product performance, operations processes, procedures and regulatory requirements is complete to performance appropriate product risk assessments.  Utilizes trending to escalate product quality risk.
• Approves, writes, revises Quality Assurance Departmental Procedures, Standard Operating Procedures, and documentation.  Identifies procedural changes needed to improve the quality management processes.  Monitors QA metrics as assigned.
• Review and approve investigations from atypical events in-house, critical complaints or inter-company complaints focusing on CAPAs and disposition of the lot(s) affected within 30 days of notifications.
• Mentors, provides guidance to others regarding the assessments of criticality, determination of affected batches (starting materials, bulk and finished product), root cause analysis, processes, assignment of CAPA, and leading technical meetings.  Escalates quality and compliance issues to quality leaders as appropriate.

 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

 

Education + Experience:

• Minimum: Bachelor’s degree in chemistry, or other scientific discipline + 8+ years of pharmaceutical, chemical or other highly regulated industry experience in manufacturing, quality or compliance
• Preferred: Master’s degree in chemistry or other scientific discipline + 5+ years of pharmaceutical, chemical or other highly regulated industry experience in manufacturing, quality or compliance

 

Skills:

• Demonstrated knowledge of FDA, cGMP, DEA regulations, EU regulations and USP.  Emphasis on management of cGMP programs.
• Demonstrated accomplishments of effectively applying cGMP and quality system regulations within the pharmaceutical industry. 
• Demonstrated knowledge of Quality Assurance, Production, Laboratories, Regulatory Compliance and Regulatory Affairs functions within a pharmaceutical productio