Quality Assurance Manager

3 weeks 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

    2 weeks ago

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

    The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Title: QA ManagerLocation: Bangalore Work form OfficeNote: looking for immediate Joiners Required skills and...

  • Quality Assurance Manager

    3 weeks 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

    3 weeks 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

    3 weeks 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...

  • Vehicle Quality Assurance Manager

    2 weeks ago

    Bengaluru, Karnataka, India, Karnataka Zeno Full time

    Zeno is looking to hire a Vehicle Quality Assurance Engineer, in this role, you will ensure that Zeno’s electric motorbikes meet the highest standards for quality, safety, and reliability. Location: Bangalore, IndiaStart Date: ImmediateAbout ZenoAn unprecedented energy transition has begun. To meet 2040 net zero goals, over 2 billion electric two-wheelers...

  • Quality Assurance Manager

    3 weeks ago

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

    About Creative Synergies Group: Global technology services company40+ Fortune 500 clients95% revenue from US, Europe, Japan based customers.Current Verticals: Transportation, Energy/Process Industry, Industrial Products, Hi-TechProduct Engineering Services (PES): Digital, Embedded, Mechanical ServicesPlant Engineering Services (Oil & Gas/ Process / Chemical...

  • Quality Assurance Manager

    2 weeks ago

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

    About Creative Synergies Group:Global technology services company40+ Fortune 500 clients95% revenue from US, Europe, Japan based customers.Current Verticals: Transportation, Energy/Process Industry, Industrial Products, Hi-TechProduct Engineering Services (PES): Digital, Embedded, Mechanical ServicesPlant Engineering Services (Oil & Gas/ Process / Chemical...

  • Senior Quality and Assurance Manager

    2 weeks ago

    Bengaluru, Karnataka, India, Karnataka Right Management Full time

    Key Responsibilities: Design, implement, and monitor quality standards aligned with program goals and client expectations for career transition services Establish and execute assurance management schedules to inspect, evaluate, and continuously improve delivery quality Drive process maturity by assessing current workflows and instituting elevated benchmarks...

  • SOFTWARE QUALITY ASSURANCE HEAD

    2 weeks ago

    Bengaluru, Karnataka, India, Karnataka Zeno Full time

    Zeno is seeking a Head of Software Quality Assurance (SQA) to define and lead the company’s quality assurance function across software platforms, including cloud backend, mobile applications, and embedded systems. Location: Bengaluru – Work from Office (5 days a week) Start Date: ImmediateAbout ZenoAn unprecedented energy transition has begun. To meet...

  • Quality Assurance Captain/Coach

    2 weeks ago

    Bengaluru, Karnataka, India, Karnataka Apica Full time

    About Us:Apica is a leading provider of innovative software solutions in the Observability space, designed to revolutionize how businesses gain insights into their systems and applications. We are dedicated to delivering cutting-edge products that streamline processes and enhance user experiences. Our mission is to empower organizations to thrive in the...