​(862) 701 - 6222

 

 

 

 

 

Regulatory Compliance & Quality Consulting Services For Regulated Industries

120 Eagle Rock Avenue, Suite 150, East Hanover, NJ  07936 

Phone: 862/701-6222

Website: http://www.GalanteLLC.com

 

QUALITY ASSURANCE/VALIDATION SPECIALIST

Job Summary

Responsible for activities involving quality assurance and compliance with applicable regulatory requirements, including but not limited to, conducting audits, reviewing/analyzing data and documentation.  Responsible for planning and executing multiple validation projects simultaneously.  Drive the validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Risk Assessment Design Specification, IQ, OQ, PQ) to completion.  Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards.  Interaction with customers will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines.

Essential Functions and Responsibilities (included but are not limited to):

  • Write standard operating procedures that are clear, concise and accurate.
  • Conduct training as required.
  • Conduct gap assessments, risk/impact assessments, and/or audits for compliance to relevant regulations, company policies and procedures.
  • Write protocols that challenge the critical parameters related to installation, operation, and performance of regulated systems.
  • Work within and develop standards and operational procedures for regulated systems.
  • Monitor regulatory and inspection trends and advise on suitable actions.
  • Support change control as validation technical resource and ensure timely completion of required tasks.
  • Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
  • Provide technical expertise, interpretation and direction to management and user in regards to computer validation, federal regulations and other quality requirements.
  • Participate in continuous quality systems improvement.
  • Interact with customers in a professional and ethical manner.
  • Assist with acquiring new customers and sell additional products and services by attending conferences, networking meetings, etc.
  • Assist with social media marketing and branding.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned.

 

Education, Experience, Skills and Abilities Required:

 

  • Bachelor’s degree in Computer Science, Chemistry, Life Sciences, Engineering or related field with 1-3 years hands on experience in computer system validation or equivalent combination of education and experience.
  • At least 1 year of industrial GMP experience in an FDA regulated pharmaceutical environment.
  • Specific knowledge of computer validation methodologies, software development life cycles, cGMPs, 21 CFR Part 11, GAMP5, regulatory requirements and ICH guidelines.
  • Knowledge of computer network and system security principles preferred.  Working validation knowledge with any of the following system/areas; automated manufacturing systems, lab systems, Empower, EDMS, LIMS, CDAS, IT infrastructure, TrackWise, Documentum.
  • Social Media Skills preferred (i.e. Twitter, Facebook, LinkedIn)
  • Proficient in Microsoft Excel, Word, and PowerPoint.
  • Excellent written and oral communication skills, good decision making skills and time management skills.

 

Job Type:  Full-time

 

 

 

To Apply, please email your resume to:

 

careers@galantellc.com