Senior Quality Assurance Manager

2 weeks ago

Karachi, Sindh, Pakistan beBeeLeadership Full time 4,000,000 - 5,000,000
Job Title: Quality Assurance Manager

At the heart of our organization lies a commitment to excellence, driven by our unwavering dedication to delivering high-quality products that meet stringent regulatory requirements and customer expectations.

Key Responsibilities:

  • Team Leadership: Directly oversee and support a team of quality control inspectors and technicians, ensuring seamless adherence to company standards and preventing delays or product unavailability.
  • Quality Control Processes: Develop, implement, and maintain quality control procedures that ensure compliance with ISO 13485 and relevant regulations, showcasing technical expertise in analytical methodology and adherence to GMP and ICH standards.
  • Inventory Management: Ensure timely disposition of raw materials, packaging materials, and finished products based on priorities set with manufacturing, marketing, and materials management departments, while overseeing inspection and testing to meet quality and efficiency standards.
  • Lab Planning and Audits: Review daily QC lab planning schedules, monitor adherence to quality standards, regulations, and best practices, and perform regular audits of QC processes.
  • Product Stability Testing: Ensure implementation of product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability.
  • Quality Data Analysis: Gather and analyze quality data, generate reports, and suggest actions for quality improvement.
  • Investigation and Resolution: Investigate quality issues or non-conformities and collaborate with other departments to resolve them.
  • Vendor Management: Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary.
  • Audit Preparation: Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance.

Requirements:

  • Pharmacy, biomedical engineering, or biotechnology degree recognized by HEC.
  • Minimum 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position.
  • Certification in quality control or quality management systems (e.g., CQE, CQA) is preferred.
  • In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing.
  • Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills required.

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