Quality Assurance Manager

22 hours ago

Tumkur Karnataka India, Karnataka Alp Consulting Ltd. Full time

Job Description

Designation: Quality Assurance Manager/Deputy Manager

Qualification: M.Pharma/ B.Pharma /M.sc (in Chemistry/Biochemistry/Industrial etc)

Desired Experience: 8 to 12 years experience in API/Pharmaceutical industry

Employee Type: Full Time, Permanent

Location: Tumkur Factory

Job Responsibilities:

  • To develop and implement a comprehensive quality assurance strategy and quality management system to ensure compliance with regulatory requirements, industry standards, and company policies
  • Ensure that all manufacturing processes, documentation, and testing procedures comply with relevant regulatory standards such as WHO GMP, ICH guideline.
  • Develop and maintain SOPs for quality assurance, and quality management activities. Ensure that these procedures are followed consistently throughout the plant
  • Coordinate and conduct internal and external audits to assess compliance with regulatory requirements and identify areas for improvement. Prepare for and manage regulatory inspections by health authorities or customers.
  • Handling of market complaints, returns/recall, deviations, OOS, validation report review .Manage the deviation and Corrective and Preventive Action (CAPA) system, including investigating deviations, identifying root causes, and implementing corrective actions to prevent recurrence.
  • Provide training and support to personnel on quality systems, regulatory requirements, and quality-related procedures.
  • Ensure accurate and timely documentation of all quality-related activities, including batch records, test reports, and validation protocols. Maintain a systematic record-keeping system for easy retrieval and compliance.
  • Collaborate with the procurement and supply chain teams to establish and maintain a supplier qualification program, ensuring that all raw material suppliers meet quality standards and specifications
  • Identify and assess quality risks within the manufacturing processes, implement risk mitigation strategies, and drive continuous improvement initiatives
  • Define and track key quality performance indicators (KPIs) to measure the effectiveness of quality systems and report on quality trends to senior management
  • Drive a culture of continuous improvement by initiating and leading quality improvement projects, conducting root cause analyses, and implementing best practices
  • Maintain detailed documentation for audit trails and regulatory submissions.
  • Timely reply to customer queries.
  • To co-ordinate with head of manufacturing, stores, production and maintenance to document any change control requirement for any changes carried out.
  • To release or reject all raw materials , intermediates, packing materials, labelling materials and finished products.
  • Drug Master files (DMF), validation master plan updation, and quality manual updation.
  • Vendor on site audits, handling and managing of audits to meet regulatory requirements.
  • Performing on site audits of vendors.
  • To review and approve all specifications, STPs, BMR, MFR.
  • Review and approve the all the procedures impacting the quality raw materials, intermediates or APIs .
  • To review and approve of all validation protocols and reports.
  • To review and approve annual product quality reviews(APQR)

  • Quality Assurance Manager

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka Zyoin Group Full time

    The Quality Manager leads, mentors, and manages the Quality Assurance team to maximise efficiency and provide the highest quality standards for our products and services. This role involves developing and implementing quality assurance strategies, overseeing testing processes, and collaborating with cross-functional teams to drive continuous improvement.Key...

  • Quality Assurance Manager

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka Tredence Inc. Full time

    QA Manager/ QA SME9-12yrsBangaloreAbout Tredence: Tredence is a global analytics services and solutions company. We are one of the fastest growing private companies in the country for three straight years according to the Inc. 5000 and we continue to set ourselves apart from our competitors by attracting the greatest talent in the data analytics and data...

  • Quality Assurance Engineer

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka iO Associates Full time

    Quality Assurance Engineer/ Sr Test EngineerBangalore | OnsiteTimings: 1 pm to 10 pm ISTDuration: 6-month C2HiO Associates is looking for a Quality Assurance Engineer/ Sr Test Engineer you will be responsible for ensuring quality of our software products by guiding Test Engineers as well as hands on developing and executing test plans, creating automated...

  • Quality Assurance Analyst

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka Theron Solutions Full time

    Quality Assurance - Analyst Job description:We have an exciting role of Quality Assurance – Analyst to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. This is an exciting role and would entail...

  • Quality Assurance Inspector- GLP

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka MS CLINICAL RESEARCH Full time

    Job Title: Quality Assurance (QA) – Clinical ResearchExperience: 8–10 yearsLocation: Indiranagar, BangaloreDepartment: Quality AssuranceAbout the RoleMSCR is seeking an experienced QA professional with strong expertise in ICH-GCP and GLP principles to ensure the highest standards of quality and compliance across clinical research and laboratory...

  • Quality Assurance Lead-Observability Platform

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka TechConnexions - Startup Hiring Specialists Full time

    Lead – Quality Assurance(Cloud & Automation | Observability Platform)Location: Bangalore, IndiaExperience:5+ years of proven experience showing increasing responsibility with bothhands-on Quality Assurance and leadership/ownership roles in Enterprise (B2B)softwareNP: Max 30 daysBudget:!2-14LPAAbout Us:We’re a leading technology firm delivering innovative...

  • Quality Assurance and Business Excellence

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka Creative Synergies Group Full time

    Quality Assurance and Business Excellence - Job Description - 8 to 10 Years Quality/CSAT Improvement in Plant and Process Engineering, Energy, Oil & Gas industryDrive Early Warnings and Risks mitigation plan across Plant Engineering BUMetrics Analysis and dashboardContinuous Improvement by means of problem solving tools and methodologies (lean / six...

  • Quality Assurance Engineer

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka Zzazz Full time

    About ZZAZZZZAZZ is building the foundation for the future of the information economy. We believe that digital content deserves more than arbitrary monetization models and opaque metrics. By assigning transparent, real-time value to the world’s data and insights, we empower everyone—from the casual user who sees the price and understands its worth to...

  • Lead Quality Assurance Engineer

    22 hours ago

    Mysore, Karnataka, India, Karnataka Capillary Technologies Full time

    Capillary Technologies is an enterprise-grade SaaS technology provider. Capillary's Al-enabled loyalty management platform offers brands comprehensive solutions for customer engagement and experiential loyalty to achieve business goals and deliver a great consumer experience. Capillary Technologies, founded in 2012, is a technology-first company that...

  • Senior Quality Assurance

    22 hours ago

    Bengaluru, Karnataka, India, Karnataka NIRA Full time

    Senior Quality Assurance (For Customer support and Collection)NIRA is building the leading financial brand for Middle India, a market of 200 million people underserved by traditional banks. With customers in 5,000+ cities & with growth engine on, we process 15,000 new loan applications daily, growing 12-15% MoM. NIRA is solving a massive problem with...