Job Title: Specialist, QA Compliance
Job Type: Full-time
Location: Bedford, Ohio
Job ID: 11380
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:
3 – 5 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…