Under general direction of the Quality & Regulatory Manager, you will be primary responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished product and investigations of product related issues and regulatory affairs.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements
It is the associate’s responsibility to observe all safety rules
Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
Primary Duties and Responsibilities
Ensures compliance with cGMP’s & Environmental, Health & Safety regulations.
Ensure compliance & execute all activities to the Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
Executes the finished product non-conformance process.
Supports document reviews to ensure timely release of finished product.
Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
Manages & executes all routine regulatory updates & submissions of finished product labelling.
Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
Ensures the company and product is registered in the appropriate markets & with agencies as required.
Reviews and approves product labeling, patient package insert and other product labeling.
Executes the document control system & record retention.
Develops, implements and maintains Standard Operating Procedures.
Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
Maintain familiarity with current regulatory trends.
Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
Performs related duties as assigned.
Experience and Educational Requirements
Minimum requirement of a BSc in a scientific discipline
Minimum of three (3) years in a cGMP facility in a Quality Assurance role
Essential to have good communication and attention to detail
Experience in the Pharmaceutical industry is essential
Experience in Medical Device regulations is desirable but not essential.
Minimum Skills, Knowledge and Ability Requirements
Excellent oral and written communication skills
Ability to effectively manage and participate in cross-functional problem-solving teams
Ability to read and understand the English language for the purpose of following instructions
Ability to develop and maintain cooperative working relationships with others.
Ability to use good judgment in order to carry out detailed instructions
Ability to work independently
Excellent teamwork and interpersonal skills
Ability to handle a variety of tasks simultaneously
Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
Ability to apply critical thinking on review of all quality related procedures and documents
Excellent attention to detail
Artwork review/Regulatory experience desirable
Computer literate; Excel, Word, Document Management System, etc..
Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs.
The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
The noise level in the work environment is generally quiet to moderate