Sr. Specialist, QA Validation

Job Title:      Sr. Specialist, QA Validation

Location:      Columbus, OH

Job Type:     Full time

Req ID:         7457

 

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 Sr. Specialist, QA Validation to join our team.  In this role, you will be responsible for approval of testing strategies and validation deliverables for various systems and processes to ensure requirements/results are compliant to the applicable business and regulatory standards.  The Sr. Specialist, QA Validation executes initial and final quality review of associated change controls for a limited number of these systems based on experience, as well as final approval of periodic reviews.  Tasks require the ability to recognize whether systems, practices and/or documents are compliant with regulatory agency and corporate expectations.  The Sr. Specialist will support other members of the team in other systems as able.

 

Key Responsibilities:

Approves validation deliverables which are compliant with regulatory guidelines and business requirements.  Acts as the project manager to ensures appropriate validation and testing strategies for cleaning, equipment and computer validation processes are developed and followed.  Ensure that the principles of validation and qualification are captured and maintained throughout the lifecycle.

• Review and approve technical documents, reports
• Ensure that all critical compliance factors have been taken into consideration and are appropriately, fully addressed
• Supports audits of Regulatory Authorities, Agencies and Corporate auditors
• Executes approvals within the change control process of the following quality systems:  cleaning validation, computer validation, equipment validation.

Approves periodic reviews which evaluate the validated state of cleaning, equipment, and computer systems.  Ensures policies, procedures and practices keep systems/processes in good standing and in a validated state.  Stays abreast of industry trends, expectations from corporate requirements and regulatory agencies.

• Contributes to the development, management and improvements of validation quality systems, including relevant policies, procedures, guidelines and templates in the area of validation.
• Partners with internal key stakeholders to establish and develop approaches, policies and procedures to optimize benefit while maintaining compliance standards.

 

Mentors and trains colleagues on policies, procedures regarding the validation of quality systems including cleaning, equipment, and computer.  Develop and present training materials, literature that is appropriate for the intended audience that will enhance learning, comprehension and retention of various validation strategies that support quality standards of excellence.

 

Other duties as assigned

Skills

• Excellent organization skills in a high-volume, fast-paced environment with demonstrated ability to manage multiple projects and deadlines simultaneously.
• Demonstrated project management skills, specifically managing multiple projects simultaneously
• Ability to quickly adapt project priorities based on changing needs of the business
• Experience with authoring and execution of Quality documentation including validation documentation, technical protoco