Pharmaceutics International Inc Hunt Valley, MD
- Posted: over a month ago
Responsible for assuring the highest quality level of the company processes and products maintaining monitoring of qualifications and validations of facilities, instruments, and equipment, performing and supporting cleaning and process validation, ensuring proper performance as per company procedures, and providing excellent service to guarantee customer satisfaction. Support validation activities for the aseptic production environment.
DUTIES & RESPONSIBILITIES:
- Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams.
- Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, aseptic, and cleaning validations. Preparation and review of associated procedures, change controls, standard operating procedures, validation master plans etc.
- Execute protocol and related activities associated with validating equipment/ systems/ utilities/ processes, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.
- Preparation, execution, and review of laboratory equipment validations and analytical data
- Initiate and investigate protocol deviations, events, exceptions and coordinate follow up with QA. Initiate, follow-up, close out and implementation of corrective and preventive actions.
- Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related but not limited to instruments, equipment, products, and processes.
- Coordinate with cross functional teams for internal and external audits. Provide all required documentation
- Additional responsibilities and functions as assigned by Supervisor/Manager
- A minimum of Bachelor’s Degree in Science/Engineering
- A background in cGMP compliance within the pharmaceutical, biologics or medical device manufacturing industry, knowledge of Validation guidelines – SOPs, FDA, ICH, EU, MHRA,OSHA, DEA and MSDS guidelines and requirements
- Ability to communicate effectively to team members and cross-functional teams. Ability to interpret documents such as Site Master Plans, Validation Master Plans, Validation protocols, Technology Transfer Documents, Master Production Records, Operating and Maintenance Instructions, and procedures manuals
- Competency: To perform the job successfully, an individual should demonstrate the following competencies: Analytical, Technical Skills, Interpersonal Skills, Team Work, Diversity, Ethics, Professionalism, Dependability, Quality, and Safety and Security
WORK ENVIRONMENT & PHYSICAL DEMANDS:
The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employees are supplied personal protection equipment (PPE), safety shoes, glasses and hearing protection whenever necessary for critical processes within manufacturing.
While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger; handle; or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required include peripheral vision, depth perception, color vision and ability to adjust focus.
Pharmaceutics International, Inc. (“Pii") is proud to be an Equal Opportunity Employer, including supporting applicants and employees with a disability or protected veterans, as well as any other status protected by law.
Pharmaceutics International Inc
AddressHunt Valley, MD
ManufacturingView all jobs at Pharmaceutics International Inc