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Job summary

Work environment

Description

General Summary:

The primary purpose of this position is to prepare documents for Master Formula (MF) updates, CRFs and other related documentation in support of the SAP project. This role supports continuous improvement initiatives and validation. This is accomplished through interaction and co-ordination of activities with all relevant departments within the organization.

Principal Duties and Responsibilities:

  • Prepare Master Formulation documentation
  • Update Master Formulation documentation
  • Prepare study protocols for execution in QC, compounding and Pharmaceutical Technology
  • Create and update SOPs relevant to Pharmaceutical Technology, Validation and Operations
  • Create and maintain filler setup sheets
  • Limited administrative support
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all training assignments and maintain personal training records
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Participate in Internal, Customer and Regulatory Audits
  • Other duties as assigned

Knowledge, Skills and Abilities:

  • Excellent Writing skills.
  • Excellent computer skills for the use of MS Office or related software

Background and Experience:

  • Bachelor’s degree in Natural Science or Engineering
  • Minimum 3-5 years experience updating GMP relevant documentation in a Pharmaceutical or Health Care setting
  • English Writing skills, Communication and project management skills, technical report writing, ability to understand technical systems.


Problem Solving:

  • The ability to schedule and prioritize workload to meet requirements of Pharmaceutical Technology and Validation departments.
  • Interact with relevant departments to assemble necessary documentation.
  • Work with operations and other departments to obtain feedback for proposed MF changes. Incorporate changes where warranted

Working Conditions:

  • Variety of working environments including all areas of the office and plant. Occasional exposure to chemicals and higher or lower than normal temperatures. On occasion flexible hours of work may be required to support Validation Protocol execution. Some lifting may be required. Routinely a mixture of standing/walking/sitting are required

Requirements

Level of education

undetermined

Diploma

Completed

Work experience (years)

undetermined

Written languages

undetermined

Spoken languages

undetermined

Equal Opportunity Employer

This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.