Senior Quality Assurance Professional

1 day ago

Hyderabad, Telangana, India beBeeQuality Full time ₹ 60,00,000 - ₹ 1,20,00,000

As a senior quality assurance professional, you will play a vital role in ensuring regulatory compliance and performing various quality-related activities.

Key Responsibilities:
  • Quality Event & Change Control:
    • Perform the QA contact role on quality events, change control records, corrective and preventive actions (CAPAs), and QA triage of distribution complaints to ensure compliance with regulations.
  • End-to-End Process Compliance:
    • Work closely with all relevant partners for the end-to-end process and ensure full compliance with good manufacturing practices (GMP) and good distribution practices (GDP).
  • Subject Matter Expert (SME):
    • Act as a subject matter expert for transportation-related quality processes, providing technical and procedural expertise to internal teams.
  • 3rd Party Collaboration:
    • Collaborate with 3rd parties (e.g., logistics and transportation service providers) to ensure alignment with service levels and to identify opportunities for performance improvement.
  • SOP & Documentation Compliance:
    • Prepare, review, and approve standard operating procedures (SOPs) and other GMP/GDP documentation, ensuring compliance with corporate, regulatory, and good manufacturing practices (cGMP) requirements.
  • Risk Management:
    • Understand and incorporate risk management strategies into the overall supply chain strategy to mitigate potential risks.
  • Provider Oversight:
    • Provide support for logistics service providers and transportation service providers by overseeing their performance and ensuring service compliance.
  • Audit & Inspection Support:
    • Support internal/external audits and inspections as part of the audit/inspection team, ensuring adherence to regulatory standards.
  • Quality Expertise:
    • Provide quality expertise and guidance to operational staff and cross-functional teams within the organization.
  • Operational Improvement:
    • Participate in operational improvement initiatives, programs, and projects aimed at enhancing efficiency and compliance.
  • Supplier Relationship Management:
    • Oversee supplier metrics, conduct performance assessments, and manage key documents to maintain strong supplier relationships and identify improvement opportunities.
  • Independent Work & Leadership:
    • Work with minimal supervision, demonstrating leadership in line with organizational values and attributes.

Requirements:

  • Bachelor's degree in science or engineering and 2+ years of professional experience in related fields.
  • Understanding of GMP/GDP requirements and their application in pharmaceutical logistics.
  • Familiarity with logistics processes for parcel, transport, and warehousing providers.
  • Experience in validation/qualification of processes, equipment, and facilities.
  • Strong technical writing skills, with experience drafting and reviewing documentation.
  • Independent, self-starter with the ability to work autonomously under pressure and within teams.
  • Knowledge of GMP/GDP and pharmaceutical regulations.
  • Energetic, detail-oriented, and highly motivated with a can-do attitude.
  • Strong change management skills.
  • Effective communication skills across all levels of the organization.
  • Proficiency with Microsoft Office tools (Excel, Word, PowerPoint).
  • Ability to multi-task and prioritize effectively in a dynamic environment.

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