Title:  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 protocols and/or technical reports.
• Strong knowledge of FDA Current Good Manufacturing Practices (cGMP) with experience in inspections, interaction with FDA, EMA or other regulatory agencies preferred.
• Demonstrated proficiency in interpersonal communications both written (technical writing required) and verbal.
• Demonstrated successful collaborative, influencing and negotiation skills to manage conflicting and/or multiple demands, priorities, opinions, and expectations.  This includes ability to facilitate meetings among various levels within the organization.
• Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications, and industry specific software such as Trackwise, SAP, RECORD, preferred.
• Ability to act independently approving validation documents.  The ability to think and react quickly to questions or issues with various regulatory agencies such as FDA, EMA is needed.  Constant subjective decisions need to be made with regulatory agency requirements in mind.
• Constant processing of information and research is needed to assure validation efforts are complete and processes are efficient and valid; proper validation positively impacts plant operation by ensuring the system functions as designed and provide the organization a ‘license to operate’.
• Demonstrated capability of developing viable solutions to any issue identified and the initiative to rectify the issue and communicated to key stakeholders appropriately and timely.

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:

• Minimum Education:  Bachelor’s degree in engineering or related scientific discipline.
• Minimum Experience:  5+ years of pharmaceutical industry experience in quality, production, engineering or laboratory setting.  3 + years of experience in validation in a pharmaceutical or highly regulated environment in any or combination of the following:  equipment qualification, process validation, computer validation and/or cleaning validation.
• Preferred Experience:  Quality Assurance experience in the pharmaceutical industry

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.