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Manager-Quality Control

2+ years
Not Disclosed
10 Nov. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Control (QC) Manager

Company: Abbott

Abbott is seeking a Quality Control Manager who will oversee and ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and safety norms in the laboratory testing areas. The successful candidate will manage quality control processes, documentation, training, and resource optimization to maintain high standards of product quality and regulatory compliance.


Main Responsibilities

Laboratory Compliance and Operations

  • Ensure adherence to current GMP, GLP, and safety norms in laboratory testing areas.
  • Maintain laboratory cleanliness and safety, including documentation of cleaning records.
  • Monitor and review compliance with laboratory guidelines, policies, and techniques.

Resource and Team Management

  • Allocate work effectively among QC team members to ensure optimal utilization of resources.
  • Provide training to subordinates to enhance analytical skills and competency.
  • Plan and manage the QC budget effectively.

Documentation and Reporting

  • Review and approve specifications, standard operating procedures (SOPs), trends, technical reports, and deviation reports.
  • Handle and maintain all documents in compliance with regulatory authority requirements, including raw data, SOPs, protocols, and training charts.
  • Investigate and document out-of-specification results, deviations, and laboratory errors, recommending corrective and preventive actions.

Sample Analysis and Approvals

  • Review and approve results for packing materials, raw materials, intermediates, finished products, stability samples, consumables, and inward water samples.
  • Provide usage decisions for raw materials, packaging materials, and finished product test samples.
  • Handle incoming materials and alternate vendor development samples.

Regulatory and Audit Functions

  • Oversee implementation of compendial changes and compliance with regulatory requirements.
  • Plan, organize, and participate in internal audits, initiating and following up on corrective actions.
  • Act as an auditor in internal audit processes and assist with technical complaint investigations.

Subject Matter Expertise (SME)

  • Play a significant role in the EPD stability SME network teams to achieve objectives.
  • Deliver GMP and technical topic training sessions at the site level.
  • Handle operations and maintenance of computerized systems/software associated with laboratory instruments.

Qualifications and Skills

Education

  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.

Experience

  • Extensive experience in quality control within the pharmaceutical, food, or manufacturing industry.

Key Skills

  • Strong understanding of GMP, GLP, and regulatory compliance.
  • Leadership skills for team management and training.
  • Analytical and problem-solving skills for deviations and out-of-specification investigations.
  • Proficiency in handling laboratory instruments and computerized systems.
  • Effective planning and organizational skills for audit and resource management.

Why Join Abbott?

Join a global leader in healthcare, contributing to the delivery of safe, high-quality products. Abbott offers a collaborative work environment, professional growth opportunities, and the chance to make a meaningful impact in the lives of people worldwide.