IPQA Associate I

3 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Summary

Sun Pharma/OHM Labs is seeking a highly motivated and detail-oriented IPQA Associate I to join our team. As an IPQA Associate I, you will be responsible for ensuring that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.

Responsibilities
  • Focus on initial deviation investigative phases related to manufacturing process deviation.
  • Respond to customer calls for assistance, documentation, and immediate corrective action associated with deviations.
  • Facilitate the use of existing management processes regarding deviations, investigations, and preventive actions.
  • Perform area assessments and ensure compliance with SOPs, Policies, and Procedures.
  • Leverage on-the-floor presence to proactively identify opportunities and provide coaching.
  • Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken, and process controls are in place.
  • Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
  • Administration and management of deviations/investigation/PAC systems in Trackwise.
  • Control materials for compliance purposes in SAP.
  • Execute the final release inspection of packaging lines.
  • Perform acceptance sample analysis for validation and investigation support.
  • Responsible for the review and approval of controlled documents.
  • Actively communicate with customers to facilitate continuous process improvement.
  • May complete specific project work such as process improvement/remediation, maintain ownership, and responsibility for specific QA processes.
Work Conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level in the work environment is usually moderate.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee 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 employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
  • Must be capable of bending and lifting, moving, and/or carrying up to approximately 20 pounds.
  • Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
  • Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Education and Job Qualification
  • Minimum of Bachelor's degree.
  • Understanding of GMPs.
  • Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
  • Knowledge of project management principles, practices, techniques, and tools.
  • Strong interpersonal and communication, both written and verbal, skills.
  • Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously.
  • A self-starter with a hands-on approach and a can-do attitude.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Experience
  • Minimum two years of experience within the pharmaceutical industry in quality function role.
  • Experience working in an international multicultural matrix organization.

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