Quality Systems & Compliance Specialist

KEY ACCOUNTABILITIES

Assist in implementing and overseeing systems relating to: CAPA, Change Control, Annual Product Review, GMP and Aseptic Training, Supplier Quality, 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.
• Keep abreast of relevant guidance documents pertaining to 503B production.
• Monitor and communicate changes in regulations of all state and federal regulatory agencies.
• Assist in new 503B product development, including collaborating on labeling, 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.

• Oversee customer complaints and adverse drug reaction program.
• Participate in product trend analysis, including owning the Annual Product Review program.
• Maintain industry 483 database and perform periodic gap analyses on observations.
• 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 the 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 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.
• Monitor the FDA Drug shortage list to ensure compliance with the 503B Guidance.
• Provide technical support in the interactions with and applications to state and federal regulatory bodies.
• Assist with customer questions as well as clinical questions from the business.
• Other duties, as assigned.

QUALIFICATIONS

• Bachelor of Science in Microbiology, Chemistry, Engineering, or other scientific discipline.

EXPERIENCE

• Minimum:
• 3 – 5 years of pharmaceutical industry experience.
• Preferred:
• Experience with 503B outsourcing, USP 797, and/or hospital IV compounding.
• Experience in Quality Systems and Compliance.
• Knowledge of sterile compounding practices.
• Knowledge of associated standards and operating procedures in relation to cGMP.
• Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.).

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.

JOB PURPOSE

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

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

• Oversee customer complaints and adverse drug reaction program.
• Participate in product trend analysis, including owning the Annual Product Review program.
• Maintain industry 483 database and perform periodic gap analyses on observations.
• 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 the 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 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.
• Monitor the FDA Drug shortage list to ensure compliance with the 503B Guidance.
• Provide technical support in the interactions with and applications to state and federal regulatory bodies.
• Assist with customer questions as well as clinical questions from the business.
• Other duties, as assigned