STERILE OPHTHALMIC CDMO

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Careers at Pillar5 Pharma

Quality Compliance Associate (1 Permanent, Full โ€“ Time Position Available)

The Compliance Associate ensure all analytical tests and test result are in full compliance with GMPs, internal SOPs, and all other applicable requirements.

Responsibilities

  • Review documentation for incoming semi-finished goods and assign appropriate disposition in the SAP system
  • Proactively expedite releases in collaboration with other departments where possible to avoid backorders
  • Maintain plant metrics for Right First Time documentation
  • Provide back up to the Quality Control Manager to support appropriate disposition of raw materials, packaging materials and MRO items
  • Participate in Regulatory Inspections and Customer Audits as required
  • Initiate and participate in local product investigations
  • Create and maintain departmental SOPs relating to release activities, as required
  • Collaborate with Project Managers to establish documentation requirements for new products & product transfers
  • Coordinate Quality Systems (primary responsibility or acting as a back-up for the other Quality Compliance Associate)
    • Vendor Qualification process โ€“ assess new Vendors and conducting external vendor audits as required
    • Product Complaint Handling – key contact for customers, initiating/reporting complaint investigations, final reporting to the customer, and any associated trending
    • Managing the Deviation and Change Control systems – including maintaining logs of closed/outstanding deviations and any associated trending
    • Annual Product Records Review completion

Qualifications

  • University degree in a relevant scientific discipline, or equivalent
  • Experience in pharmaceutical manufacturing in a quality role (minimum of 2 years)
  • Superior communication (oral and written), organizational and documentation skills
  • Working knowledge of Good Manufacturing Practices, Good Laboratory Practices, and Regulatory Guidelines with several years of experience in the pharmaceutical industry
  • Proven leadership ability as evidenced by increasing responsibility in employment history
  • Ability to work effectively with regulatory agencies, contract manufacturers, external customers, technical and non-technical personnel
  • Knowledge of computerized information systems, including MS Office (notably MS Access) and SAP

Application process: Please send your resume using the form below.