Validation Supervisor or Manager

Nesher Pharmaceutical has an immediate opening for an experienced Validation Supervisor.  Will consider a Manager position for the right candidate.

Summary

Supervise the day-to-day validation operations for cleaning, process and packaging validation equipment and utilities qualification, and computer systems validation.  Create, review and implement cleaning, process and packaging validation, equipment and utilities qualification, and computer systems validation master plans, polices, standard operating procedures (SOPs), validation plans, and protocols.  Write Final Summary Reports that summarize executed qualifications/validations.   Prioritize, create and manage project plans. Assign and monitor the work of staff members to ensure achievement of Validation Master Plans and Projects pertaining to cleaning validation, process and packaging validation, equipment and utilities qualification, and computer systems validation.  Perform workload and headcount analyses to determine Validation Team requirements to deliver required projects on time.  Lead NVRB meetings.  Work with the Director, Quality Assurance to ensure validation plans and protocols meet current FDA regulatory requirements.  Maintain strict compliance with cGMPs, company SOPs, and applicable state and federal regulations.   

Essential Duties and Responsibilities

• Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to staff members.
• Provide supervision of the validation function. 
• Develop, implement and maintain company-wide programs for cleaning, process and packaging validation, equipment and utilities qualification, and computer systems validation.  Ensure these systems are in compliance with guidelines and are documented and tracked in an orderly manner as per area procedures.
• Coordinate efforts among quality assurance, quality control, research and development, engineering, operations, and validation personnel to properly validate and qualify products and processes, equipment and utilities, and computer systems in accordance with time and event schedules developed. 
• Develop validation project plans in accordance with company scheduled events and projects. 
• Resolve issues pertaining to validation while remaining compliant to procedures and policies.
• Work with the research and development (R&D) processes to provide a high degree of assurance that R&D lots are controlled and cleaning validations, where appropriate, are completed.
• Review R&D QbD and technical transfer documentation to ensure appropriate process controls and specifications are defined and in place for critical process parameters and quality attributes.
• Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D) and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
• Supervise the preparation, review and execution of written cleaning validation protocols that assure equipment has been cleaned to meet pre-determined acceptance criteria for residual active and detergent, and bioburden levels.
• Supervise the preparation, review and execution of process and packaging validation protocols that assure processes have been validated to meet all predetermined acceptance criteria.
• Supervise the preparation, review and execution of equipment and utilities qualification protocols to assure that equipment meets the designed requirements as determined by the system owner and/or engineering.
• Supervise the preparation, review and execution of computer system protocols to assure that the software and hardware comply with the design requirements as determined by the system owner and/or IT.
• Review and approve the validation section of all change control notices to ensure each process continues to operate within its designed parameters and maintains the validated state.  Review and approve procedures/protocols that have been established to revalidate the process in the event of a process or equipment change.
• Participate in the generation and approval of investigations and CAPAs associated with process, packaging and cleaning validation, equipment qualification activities, and computer systems. Ensure protocols, verifications, test scripts, validation plans, and summary reports generated during process, packaging, cleaning validation, equipment and utilities qualification activities, and computer systems are properly filed and available for retrieval and optimum use.
• Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company.  Work proactively to maintain the highest level of compliance in all areas.  Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs.
• Prepare and/or review SOPs and policies as required relating to process validation, packaging validation, cleaning validation, equipment and utilities qualification, and computer system validation as needed.
• Discuss process, packaging and cleaning validation, equipment qualification, and computer system validation concepts with customers or regulatory agencies as required during reviews or inspections.
• Supervise activities of contractors and external consultants as needed.
• Prepare department and individual goals that are in line with Company and departmental objectives.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals.  Participate in selection of personnel and provide for their effective and thorough training. Evaluate performance in accordance with company guidelines for all staff members, to include preparing and conducting performance evaluations.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Thorough knowledge and understanding of governmental requirements related to current Good Manufacturing Practices and other appropriate government regulations and requirements.
• Knowledge of Statistical software and calculations.
• Knowledge of manufacturing processes, sampling techniques and sample size determination, government regulations and guidelines pertaining to those areas.
• Must have knowledge of equipment and utilities qualification, process and packaging validation, facility commissioning and qualifications, computer system validation, master validation policies and protocol generation, and protocol execution.
• Strong understanding of cGMP's and validation/qualification concepts.
• Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
• Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
• PC proficiency using Microsoft Office (including Microsoft Project) and statistical software, such as Minitab.
• Ability to effectively interface with FDA, DEA and technical personnel at various levels.
• Ability to analyze pharmaceutical processes to determine critical parameters, critical quality attributes and design testing in the form of protocols to ensure robust and repeatable processes.
• Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints as well as cGMPs and SOPs.
• Ability to accurately perform mathematical calculations and statistical analysis required by work assignments.

EDUCATION/EXPERIENCE
Bachelor's degree in Engineering, Chemistry, Pharmacy or related Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.

Two years' supervisory experience, preferably in validation of solid dosage pharmaceuticals.

Experience in 21 CFR Part 11 desired.

Work Environment

 The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
    

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Validation Supervisor or Manager Jobs at Nesher Pharmaceuticals (USA) LLC