Sr. Quality Assurance Officer - Sterile
Karachi, Pakistan
1d ago

Job Description

  • Ensure effective execution of Product Quality Assurance at shop floor.
  • Ensure effective implementation of Quality Systems at shop floor.
  • Effectively participate in the identification of quality events and deviations.
  • Support in handling deviation management process from event generation to closure.
  • Provide support in handling quality investigations with cross functional groups.
  • Support change management process by providing necessary support in change control process.
  • Perform effective In-process Control at shop floor to ensure product quality at every stage.
  • Perform exhaustive Line Clearance procedures in line with applicable process
  • Review batch documents to ensure completeness and correctness of data to ensure GMP compliance.
  • Proactive approach for mix up prevention with ability to identify situations leading to mix ups.
  • Support in management of Product Technical Complaints investigations to identification of root cause.
  • Facilitate in management of Corrective and Preventive actions resulting from any quality event.
  • Facilitate Product Quality Review and identify improvement in manufacturing and quality process.
  • Support self-inspections in GMP areas as part of Site Self Inspection team.
  • Contribute in Global Quality Audit and Regulatory Inspections.
  • Stay up to date with all applicable Sanofi quality guidelines and ensure compliance of same.
  • Support in performing gap assessment of Global Quality guidelines with local procedures.
  • Stay up to date with all applicable local and GMP regulations and ensure compliance of same.
  • Ability to familiarize self with principles and tools of Quality Rik Management.
  • Good presentation skills with ability to provide training to shop floor teams.
  • Responsible to prepare and report Product Quality Assurance KPIs and trend analysis of same.
  • Support Data Integrity Compliance program at the shop floor in line with applicable procedures as ALCOA+.
  • Ensure the periodical revision and updates of SOPs in line with applicable Sanofi Guidelines.
  • Effectively participate in the implementation of the Sanofi Manufacturing System (SMS) at site.
  • Active participation in daily cross functional +QDCI Level 1 meetings at shop floor.
  • Quick learner with ability to grasp quality concepts quickly.
  • Strong Quality mindset with the ability to support Quality Culture across the site.
  • Team player with ability to effectively work with cross functional teams.
  • Leadership behaviour with ability to influence quality decisions in all situations.
  • Innovative approach to identify and execute Quality Improvement Projects
  • Digital mindset with the ability to initiate technology innovations projects at site.
  • Participate in Behaviour Observation Safety Program of site to ensure safety culture at site.
  • Education :

  • Pharmacist (Pharm. D / B. Pharm)
  • Chemist / Microbiologist / Biotechnologist with relevant experience.
  • Lead competencies

  • Act for Change
  • Cooperate Transversally
  • Experience :

  • 01 to 02 years in Quality Operations or Production.
  • Fresh graduates are also encouraged to apply
  • At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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