Batch Record Reviewer

Job Title: Batch Record Reviewer

Job Type: Full-time

Location: Bedford, Ohio

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB PURPOSE:

The Specialist, QA Compliance will support the Quality Group by implementing and maintaining Quality Compliance policies/strategies in alignment with all regulatory authorities/guidance and Hikma Corporate plans and policies. The Specialist, QA Compliance will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements.

KEY ACCOUNTABILITIES:

Assist in implementing and overseeing systems relating to: CAPA, Change Control, Annual Product Review, GMP, Supplier Quality, Recalls, Field Alerts, Internal & External Auditing, Customer Complaints, 483 Gap Analysis, etc.

• Assist with ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
• Monitor and communicate changes in regulations of all state and federal regulatory agencies.
• Assist in collaborating on stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.

Primary Accountabilities:

NOTE: The primary accountabilities below describe the general content of and requirements of this position. This is not an exhaustive statement of duties.

• Support inspection readiness program
• Oversee customer complaints and adverse drug reaction program.
• Participate in product trend analysis, including owning the Annual Product Review program.
• Perform periodic gap analyses on 483 observations and new regulatory guidance’s.
• Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
• Manage execution of internal and external audits to assess and maintain compliance with regulatory and customer requirements.
• Assist the Quality Group in response to regulatory requests and inspection audits. Review, prepare, and/or approve all written responses to audits and inspections.
• Oversee Supplier Quality program, including review and approval of Supplier Qualification & Performance documents (i.E., supplier audits, notifications, CAPAs, etc.). Initiate, review, and/or approve Quality (and Technical) Agreements.
• Participate in the preparation and execution of dashboard metrics evaluating key performance indicators for all departments.
• Participate / execute Internal Audits as per Annual schedule, compile report, review CAPA responses.
• Participate in the administration of Site Projects.
• Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
• Provide technical support in the interactions with and applications to state and federal regulatory bodies.
• Support for Documentation control activities (issuance of Batch Records, Logbooks, etc) as a backup.
• Other duties, as assigned.

QUALIFICATIONS:

• Bachelor of Science in Pharmacy, Chemistry, Microbiology, or other scientific disciplines.

EXPERIENCE:

Minimum:

• 1 – 3 years of pharmaceutical industry experience.

Preferred:

• Experience in Quality Systems and Compliance.
• Knowledge of Injectables manufacturing process / practices.
• Knowledge of associated standards and operating procedures in relation to cGMP.

SKILLS:

• The ability to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback, and recognition.
• The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
• The ability to manage multiple resources and be accurate and current with data and information.
• Ability to communicate technical information to non-technical personnel.
• A broad perspective to organize objectives, both long-term and day-to-day activities.

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.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third parties in the event a candidate they refer is hired by Hikma.

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.