POSITION PURPOSE
A brief summary of the purpose this position must fulfill.
Ensure Kavis Pharma LLC is in compliance with cGMP regulations and all other regulatory guidelines governing Kavis Pharma LLC operations related to the development, manufacture, testing, and distribution of pharmaceutical products and components. Responsibilities include compiling and analyzing trends, site metrics, Annual Product Review reports and compliance program metrics.
Perform job functions in accordance with current Good Manufacturing Practices, and all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
- Compile, analyze and report data for monthly Quality metrics and Management Review to Quality management.
- Accountable for Site Quality Council, and Management Review Meeting.
- Perform data analysis and trending of quality metrics and assess the need for actions in response to trends.
- Compile, analyze and complete reports for Annual Product Review (APR) for established drug products per approved schedule.
- Support to Compile, analyze and complete reports for Continuous Process Verification (CPV) for established drug products.
- Performs internal audits and complete reports.
- Execute and oversee execution of CAPAs related to quality improvement initiatives associated with the Global Quality Action System. Ensure CAPAs are effective in their response to the required actions.
- Provide thorough compliance reports and assessments to Quality management.
- Provide information required for APRs, CPVs, Management Review, Site Metrics and other business needs and assist with KPI metrics reporting and evaluation.
- Perform Gap Assessments to ensure local procedures are aligned with global SOPs and Policies.
- Perform other duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
Must possess knowledge of Quality systems for the Pharmaceutical Industry, cGMPs, and Pharmacopoeia (USP, EP) requirements. Knowledge of current expectations and trends of FDA and other regulatory authorities in the areas of cGMPs is essential. Must have knowledge of quality auditing and operations of a pharmaceutical manufacturing facility. Must possess knowledge of familiarity with computers and various software such as MS Word, MS Excel, Documentum, Trackwise, Minitab, etc.
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Must have the ability to interpret and analyze data related to manufacturing, testing, and quality control.
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Understanding long-term trends in production data and quality results.
SKILLS AND ABILITIES
Must possess skills in organization and prioritization; must be detail oriented and have the ability to perform multiple projects/tasks simultaneously with minimal supervision; must be a self-motivator and independently find way to increase departmental efficiency. Must possess strong verbal, leadership and communication skills, and well–developed ability to constructively work across functional areas to achieve results. Must be able to review, interpret, and discuss complex governing regulations, precedent interpretations, and current applications. Must be adept at independent decision-making. Must possess a professional and cooperative attitude as a team player with all departments. Must project a professional company image while interacting with management of various subsidiaries and outside vendors. Must possess excellent proofreading strong technical writing skills. Must be proficient in MS Office – Word, PowerPoint, and Excel – and statistical analysis programs – i.e., Minitab.
SUPERVISION
Position functions semi-autonomously. Position directly reports to the Associate Manager, QA Compliance.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
Internal Auditing certification (e.g., ASQ-CQA) preferred, but not required.
LANGUAGE SKILLS
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Be able to work in an office, manufacturing and laboratory work environment.