Job Description

PRIMARY RESPONSIBILITIES

· Knowledge of pharmaceutical liquid manufacturing operations and knowledge of regulatory requirements/guidelines in the area of validation.

· Responsible for risk analysis, process validation, cleaning validation, and equipment qualification required for new products, processes, and equipment in addition to any changes to existing products, processes and equipment.

· Manage and successfully execute several validation projects concurrently by teaming up with internal and external contacts with minimal supervision.

· Capable of meeting project objective timelines by successfully planning, tracking and executing validation projects that may potentially cover all three shifts of manufacturing.

· Excellent verbal communication and technical writing skills with strong attention to detail

· Create and/or update intra and interdepartmental procedures, policies, and supporting documentation.

· Demonstrate problem-solving and troubleshooting skills.

· Stay current with validation regulatory requirements.

· Knowledge of FDA regulations, pharmaceutical GMPs (21 CFR 210, 211 and 820), and/or ICH regulations.

· Must have prior knowledge of instrumentation and/or calibration processes.

· Assist with intradepartmental projects and activities as necessary.

· Ability to work in a fast-paced environment while supporting multiple and changing priorities

· Prepares all protocols and reports for validation work.

· Provides input, reviews, and approves User Requirements Specifications (URS).

· Provides input on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and Commissioning protocols.

· Coordinates all validation activities by constant communication with affected departments and personnel.

· Execute, oversees, and reviews validation area processes and procedures.

· Troubleshoot and resolve issues with equipment and processes as it impacts the validated state

· Controls and organizes all validation documents.

· Ensures equipment used for qualification purposes is properly maintained and calibrated.

· Create and/or update intra and interdepartmental procedures, policies, and supporting documentation

· Competent with GMP’s concepts, practices and procedures as defined in 21 CFR Parts 210, 211, and 820.

· Assist with technical writing and any other activities assigned.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

· Ability to work independently be self-motivated and organized.

· Ability to complete assignments in a team-oriented environment.

· Excellent user knowledge of Microsoft Excel, Word, Outlook, Power Point, and Project

· Technical writing and strong attention to detail required.

· Excellent verbal and written communication skills.

· Experience with aseptic processes preferred.

· Hands-on experience in qualification of one or more of the following: refrigerators, freezers, incubators, autoclaves, liquid filling machines, isolators, ISO classified environments, utilities (steam, water, compressed air), media fills, sterilization processes, environmental monitoring, process control systems, cleaning validation, process validation.

· Willing and capable of working on various projects with cross-functional teams at all levels within the organization.

· Willing and capable of assisting in the process, equipment, and cleaning development along with managing associated validation activities.

· Ability to work in a fast-paced environment while supporting multiple and changing priorities.

· Work hours may include off-shifts, weekends, and holidays.

QUALIFICATIONS

· Bachelor’s in Chemical or Biological Sciences/Engineering preferred.

· 5+ years of Quality Assurance experience in the pharmaceutical manufacturing environment.

· Knowledge in aseptic manufacturing process is preferred.

(PAY RANGE DEPENDS ON EXPERIENCE)

Company Description

We are a Prime Manufacturer of Private Label and Contract Manufacturing Over-The-Counter (OTC) Eye Drops. We also offer Multi-Purpose Solution products to meet your Contact Lens care needs. K.C. Pharmaceuticals, Inc. is committed in meeting the requirements of the Current Good Manufacturing Practices (CGMP) laid out in the Code of Federal Regulations (CFR) issued by the US Food and Drug Administration (FDA). We are devoted in producing finished pharmaceuticals and medical devices that uphold high quality standards in today’s consumer market. As part of our ongoing efforts in maintaining compliance, we have been keen in implementing many systems and procedures designed to improve product quality and ensure customer satisfaction. Since our manufacturing paradigm is “Building Quality Into Products,” we have various internal quality control and quality assurance checkpoints through audits, inspections, reviews, and tests to guarantee that all quality requirements have been met.