Quality Management Systems Specialist

summary

Perform Quality Management System (QMS) document review of multiple sites. Guide the site in compliance of observations and review of Deviations, Change Controls, Internal and External Audit Documents, Market Complaints and Effectiveness of CAPAs. Train site personnel in Quality Management System when required.

essential Duties and Responsibilities

• Prepare and follow plan for on-site review of QMS documents.
• Review Change Controls and Internal and External Audit documents of multiple sites.
• Approve observations, categorization and response verification to QMS review.
• Discuss and resolve major review findings with Site Quality, Manufacturing Head and Critical Quality Leads.
• Review trends for identification of emerging trends and identify specific areas for improvement.
• Support site to enhance completeness towards increasing 'right first time' documents.
• Coordinate with site for review and understanding of observations and system implementation.
• Provide onsite training to investigators based on trend data.
• Assist sites in regulatory or external inspections for site readiness.
• Participate in meetings with management as required.
• Participate in the development of new Quality Management System Initiatives.
• Establish and monitor appropriate document turnaround time.
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KNOWLEDGE/SKILLS/ABILITIES

• Demonstrated thorough knowledge and understanding of cGMP and FDA.
• PC proficiency using Microsoft Office required; Trackwise is preferred.
• Outstanding oral communication and conflict resolution skills with all levels of the organization.
• Ability to think critically and apply critical thinking processes to investigations, CAPAs, auditing, and data reviews.
• Highly organized and able to work comfortably with accelerated work pace.
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EDUCATION/EXPERIENCE

• Bachelor's degree in the sciences or related technical field.
• Five years' experience in a Quality role that involves conducting review of investigations, changes, deviations, and in-process checks in a pharmaceutical environment.
• A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.  

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 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 Quality Management Systems Specialist Jobs at Nesher Pharmaceuticals (USA) LLC