Nesher Pharmaceuticals (USA) LLC
  • 22-Dec-2017 to 20-Feb-2018 (CST)
  • Quality
  • Pennington, NJ, USA
  • Full Time

Competitive Benefits Package


summary

 

Perform review of formulation and analytical documents generated during generics drug product development, responsible for the review of laboratory data associated with the Quality oversight of R&D Operations. Ensure adherence to CD commitments by identifying and escalating specific issues to Critical Quality leads(CQL).

 

essential Duties and Responsibilities

 

  • Facilitate and ensure the timely review and approval of documents generated by the formulation and Analytical Development Departments.
  • Ensure the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are identified and challenged during the drug product development phases.
  • Ensure the Design Space is created during development.
  • Facilitate and ensure the timely review and approval of scale up protocols and reports.
  • Ensure the suitability of analytical methods for API, Formulation and In-process.
  • Review the risk assessments prepared during the drug product development.
  • Participate in stage gate reviews.
  • Prepare, review, and approve the required Quality Policies and Procedures of Development Quality Assurance.
  • Facilitate the timely review of Equipment Qualification Documents of Generics Drug Development.
  • Facilitate and ensure the timely review and approval of Analytical Method Validation Protocols, reports and method Development Reports.
  • Review and approve new and revised Specifications for New products.
  • Assist in the tracking of regulatory deficiencies and response reviews.
  • Prepare monthly reports and participation in departmental meetings as required.
  • Identify and escalate specific issues to CQL for compliance and support.

KNOWLEDGE/SKILLS/ABILITIES

  • Demonstrate thorough knowledge and understanding of the Development Quality Assurance function.
  • Computer proficiency using Microsoft Office required; Minitab preferred.
  • Outstanding oral communication and conflict resolution skills with all levels of the organization.
  • Ability to think critically and apply critical thinking processes to drug product life cycle management.
  • Highly organized and able to work comfortably with accelerated work pace.

EDUCATION/EXPERIENCE

  • Bachelor's degree in the science or related technical field.
  • Five years' experience in a R&D Quality role that involves conducting review of investigations, changes and deviations, 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.
Nesher Pharmaceuticals (USA) LLC
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share this Page
.
Logo Home Careers Products Locations Grow With Us