Nesher Pharmaceuticals (USA) LLC
  • 29-Mar-2018 to 28-May-2018 (CST)
  • Quality
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


summary

Manage day-to-day validation operations for cleaning, process and packaging validation, and equipment qualification plans and protocols. Create, review and implement cleaning, process and packaging validation, and equipment qualification master plans, polices, standard operating procedures (SOPs), validation plans and protocols. Write Final Summary Reports that summarize executed qualifications/validations.   Assign and monitor the work of staff members to ensure achievement of Validation Master Plans pertaining to cleaning and process validation, and equipment qualification. Work with the Associate Director of Validation to ensure validation plans and protocols meet current FDA regulatory requirements. Maintain strict compliance with cGMPs, company SOPs, and other state and federal regulations.

 

essential Duties and Responsibilities

  • Manage validation function.
  • Manage the development, implementation and maintenance of company-wide programs for cleaning, process and packaging validation, and equipment qualification. Ensure that these systems are in compliance with guidelines and are documented and tracked in an orderly manner.
  • Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the business. Work proactively to maintain the highest level of compliance in all areas of responsibility. Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs.
  • Manage the coordination of efforts among quality assurance, quality control, manufacturing, research and development, engineering and validation personnel to properly validate the products and processes of the company in accordance with time and events schedules developed. 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.
  • Manage 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.
  • Manage the preparation, review and execution of process and packaging validation protocols that assure processes have been validated to meet all predetermined acceptance criteria.
  • Manage the preparation, review and execution of equipment qualification protocols to assure that equipment meets the designed requirements as determined by the system owner and/or engineering.
  • Manage the review and approval of the validation section of all change control notices to ensure each process continues to operate within its designed parameters. Review and approve procedures 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, and equipment qualification activities. Ensure protocols, verifications, validation plans and summary reports generated during process, packaging and cleaning validation, and equipment qualification activities are 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, and equipment qualification as needed.
  • Discuss process, packaging and cleaning validation, and equipment qualification concepts with customers or regulatory agencies as required during reviews or inspections.
  • Manage activities of contractors and external consultants.
  • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to staff members.
  • 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. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards 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 Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, and Viscometer.
  • Knowledge of Statistical software and calculations.
  • Knowledge of manufacturing processes, sampling techniques, government regulations and guidelines pertaining to those areas.
  • Strong understanding of cGMP's and validation/qualification concepts.
  • Excellent written and verbal communication skills; highly organized and detail-oriented.
  • Proven skills to effectively manage and communicate with direct reports with different skill levels within various disciplines of validation.
  • Ability to effectively and directly interface with FDA, DEA and technical personnel at various levels.
  • Capable of effectively communicating, directing, guiding personnel who are not direct reports in various aspects of cGMPs.
  • Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing  in the form of protocols to ensure robust and repeatable process. Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution.
  • PC proficiency using Microsoft Office.
  • Good conflict resolution skills.
  • Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints as well as cGMP and SOPs.
  • Ability to accurately perform mathematical calculations required by work assignments.

EDUCATION/EXPERIENCE

  • Bachelor's degree in Chemistry, Pharmacy or related Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
  • Five years' applicable experience in a QA/QC position, with at least two years' supervisor experience, preferably in 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:

  1. Frequently required to sit and/or stand, walk, talk and hear.
  2. Constantly required to use hands and fingers to operate office machines and equipment.
  3. Frequently required to reach with hands and arms.
  4. Occasionally required to stoop, kneel and crouch.
  5. Required to 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.
  6. Required to exert a negligible amount of force continuously and/or up to five pounds of force frequently and/or up to 25 pounds of force occasionally 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. Normal office conditions.

 

Personal Protective Equipment is required to be worn if assigned to perform work or tasks in specific production areas.

  • Eye protection (safety glasses).
  • Foot Protection (steel or composite toe safety shoes).
Nesher Pharmaceuticals (USA) LLC
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