Supervisor, Quality Operations

1 week ago

Hamilton, Ontario, Canada Allergan Full time
Supervisor, Quality Operations (Biologics)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie onTwitter ,Facebook ,Instagram ,YouTube andLinkedIn .

Job Description

The Quality Operations Supervisor is responsible to oversight the quality system execution on themanufacturing and production areas at all times. Incumbent is required to observe, document, discuss,investigate and approve quality adverse events related to the manufacturing of the product. Position'sfunctions are essential in the resolution of quality system activities that can potentially impact releaseof safe and effective product to the market. Quality Operations Supervisor is responsible to ensurehighest quality and compliance of released batches at the AbbVie Operations Singapore, TuasSingapore site. Incumbent will have supervision responsibilities of exempt and or non-exemptpersonnel within the Quality Operations Area.

Responsibilities

  • Supervise a team of Quality Operations Specialists to ensure that incoming material release, QC,warehouse and production at AbbVie Operations Singapore is performed as per current goodmanufacturing practices, according to local procedures and as per specifications andmanufacturing directions approved by AbbVie Operations Singapore.
  • Lead and act as Subject Matter Expert in change management to ensure system effectiveness andefficiency.
  • Lead the team to perform review/audit of incoming material inspection package which includesreceiving, sampling and testing compliance.
  • Oversee and perform the timely of review of batch records of incoming materials, API/BDS for fullcompliance to written procedures prior to approval and release.
  • Ensure that all quality goals/metrics are met, and all practices and procedures comply with AbbViepolicies and applicable regulations for the Quality areas under his /her responsibility.
  • Review and approve investigations and CAPA actions to assess level of consistency and
  • Ensure investigations of plant events are completed thoroughly and documented accurately andare included in the plant CAPA system. Perform product impact analyses for plant events andplace incoming material and/or product on QA Hold where appropriate.
  • Responsible for Annual Product Quality Review and Product Quality Assurance
  • Lead/liaise with other departments for cross-functional issues and/or projects/initiatives forcontinuous improvement by maintaining an effective liaison and cooperative relationship with otherstakeholders.
  • Maintain performance measurements of the Change management, incoming material release,batch record review and product release processes to enable the continuous improvement cycle.
  • Proactively participate and support new product introduction, operation excellence projectsassigned by management as appropriate.
Qualifications

Education

  • Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
  • Master Degree desired but not required.

Experience

  • Quality/compliance management skills. This position requires knowledge of quality / compliance management as well as regulations and standards affecting APIs /Biologics.
  • Minimum of 8+ years of pharmaceutical, biopharmaceutical experience in Quality and/or
  • Compliance (GxP) environment.

Skills

  • Ability to quickly know products and processes in order to assess quality issues
  • Total commitment to quality and maintain a high standard of work at all times
  • Demonstrates the highest levels of integrity and a strong work ethic
  • Good knowledge of GxP requirements and regulations
  • Good level of decision making and problem solving
  • Good planning and scheduling skills
  • Good communication skills both verbal and written
  • Good interpersonal skills
Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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