Collins McNicholas

The Senior Manager of QA Operations would be responsible for all aspects of assigned QA Team.

This would include providing leadership and support to direct reports. provide oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.

Responsibilities:

  • Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions:
    • Master records
    • executed records
    • failure investigations
    • Change Controls
    • SOPs
    • validation protocols and summary reports
    • incursion
  • Approves various documents relating to area function, including those listed above
  • Organizes QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
  • Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
  • Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
  • Provides advice and direction to other company departments on quality issues.
  • Participates in regulatory and customer audits.

Requirements:

  • BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired.
  • Minimum 5 years’ experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience.  

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270

 

 

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