Talent.com
General Manager - Quality Assurance (Injectable)
General Manager - Quality Assurance (Injectable)Biotech Healthcare • Rajkot, Gujarat, India
No longer accepting applications
General Manager - Quality Assurance (Injectable)

General Manager - Quality Assurance (Injectable)

Biotech Healthcare • Rajkot, Gujarat, India
6 hours ago
Job description

Role Objective

A key objective of this position is to ensure adherence to global regulatory standards and best practices while maintaining robust quality systems. The role focuses on implementing effective quality processes, driving continuous improvement initiatives, and fostering a strong culture of compliance to guarantee the safety, efficacy, and quality of injectable products.

Desired Candidate Profile

  • M.Sc. / M.Pharm / B.Pharm / B.E. in Life Sciences or Engineering.
  • Minimum 16+ years of relevant leadership experience in Quality Assurance, including Site Quality leadership.
  • At least 10+ years of experience in supervising, managing, and directing teams.
  • Demonstrated knowledge of cGMPs, global health authority regulations and guidelines, and Quality Management Systems.
  • Strong technical expertise with proven ability to lead quality operations in a fast-paced manufacturing environment.
  • Excellent interpersonal, leadership, and stakeholder management skills.

Role & Responsibilities

  • Lead the Quality Assurance function across the site, ensuring compliance with global regulations and internal quality standards.
  • Establish, monitor, and enhance Quality Management Systems to ensure operational excellence.
  • Partner with Site Operations, Regulatory Affairs, Clinical Operations, and Finance to align quality objectives with business goals.
  • Ensure timely review and approval of validation protocols, master manufacturing records, deviations, CAPAs, and change controls.
  • Oversee audits and inspections by regulatory authorities and ensure prompt and effective closure of observations.
  • Drive continuous improvement initiatives to enhance product quality and operational efficiency.
  • Develop, mentor, and lead a high-performing QA team by fostering accountability, innovation, and learning.
  • Ensure effective training of personnel on quality systems, regulatory requirements, and company policies.
  • Support risk management and decision-making processes to uphold product quality and patient safety.
  • Functional Skills Required

  • Strong understanding of cGMP regulations and global quality guidelines.
  • Proficiency in Quality Management Systems, audit processes, and risk-based approaches.
  • Ability to evaluate technical and scientific data for decision-making.
  • Expertise in deviation management, CAPA systems, and change control processes.
  • Knowledge of aseptic manufacturing and injectable product quality standards.
  • Competency in leading regulatory inspections and managing compliance requirements.
  • Behavioral Skills Required

  • Strong leadership presence with the ability to influence at all levels of the organization.
  • Analytical and logical reasoning skills with a solution-oriented mindset.
  • High sense of urgency with a focus on timely and effective decision-making.
  • Collaborative approach, fostering cross-functional teamwork and alignment.
  • Resilience and ability to manage complex challenges while maintaining focus on long-term goals.
  • Commitment to building and nurturing a culture of quality, compliance, and continuous improvement.
  • Team Size to be Handled :

  • Lead and supervise a team of 13-15 team members, reporting to the VP – Corporate Quality.
  • Important Links :

  • Website : https : / / biotechhealthcare.com /
  • LinkedIn : https : / / www.linkedin.com / company / biotechhealthcare /
  • Instagram : Biotech Vision Care
  • Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, sexual orientation, disability, etc.

    Create a job alert for this search

    Quality Assurance Manager • Rajkot, Gujarat, India

    Related jobs
    Test Manager (SAS Testing)

    Test Manager (SAS Testing)

    EXL • rajkot, gujarat, in
    Excel-based validation templates and reporting.Support go-live readiness through.Excellent analytical, communication, and problem-solving skills.Show more
    Last updated: 17 days ago • Promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    Magna Technology Group • Rajkot, IN
    Magna is looking for an experienced, detail-oriented, and collaborative QA Engineer to ensure our software applications are high-quality, functional, and user-friendly prior to release.This role wi...Show more
    Last updated: 13 days ago • Promoted
    Quality Assurance Test Lead

    Quality Assurance Test Lead

    Ascendion • rajkot, gujarat, in
    We’re Hiring for QA Test Lead – FHIR / HL7 & InterSystems IRIS | IMMEDIATE JOINERS ONLY.If you have the passion and potential to. QA initiatives in healthcare data testing.Bangalore / Hyderabad / Pune / Che...Show more
    Last updated: 18 days ago • Promoted
    Process Engineering Manager

    Process Engineering Manager

    Aarti Pharmalabs Ltd. (APL) • Rajkot, IN
    For all the Heat and Mass transfer calculations.To prepare P&ID ,PFD for the manufacturing process.Debottlenecking of process equipments. Effective Utilisation of equipments to increase the producti...Show more
    Last updated: 9 hours ago • Promoted • New!
    Senior QA Engineering Lead & Technical Product Manager

    Senior QA Engineering Lead & Technical Product Manager

    Teachally • Rajkot, IN
    Senior QA Engineering Lead & Technical Product Manager.We're seeking an experienced QA professional who can wear multiple hats—leading our quality assurance initiatives while driving product delive...Show more
    Last updated: 2 days ago • Promoted
    Quality Assurance Analyst

    Quality Assurance Analyst

    CareerUS Solutions • Rajkot, IN
    Quality Assurance (QA) Analyst – Job Description.The Quality Assurance Analyst is responsible for testing software applications, identifying defects, and ensuring high-quality deliverables.The role...Show more
    Last updated: 9 days ago • Promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    GoQuant • Rajkot, IN
    Job Description : QA Engineer (Paid).GoQuant is a financial technology company dedicated to providing high-performance trading solutions for digital assets. We empower professional traders and instit...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Engineer (m / f / d) – Finance & Indexing

    Quality Assurance Engineer (m / f / d) – Finance & Indexing

    BITA • Rajkot, IN
    BITA is a Fintech company with the mission of disrupting the index and systematic investment industry.Through advanced software, state-of-the-art infrastructure, and high-quality data, we empower o...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Automation Engineer (Java)

    Quality Assurance Automation Engineer (Java)

    Huxley • Rajkot, IN
    Huxley is a recruitment agency helping top talent find exciting roles in the fintech industry.Automation QA Engineer (Hybrid). We are seeking a highly skilled QA professional who can ensure exceptio...Show more
    Last updated: 9 days ago • Promoted
    Software Quality Assurance Engineer

    Software Quality Assurance Engineer

    TerraGiG • Rajkot, IN
    Notice Period : Immediate Joiner.Job Description for CSM Automation Engineer : 2-3+ years Automation : .Industry level project experience in any language / automation tool, preferably Selenium or Appiu...Show more
    Last updated: 14 days ago • Promoted
    Quality Engineer

    Quality Engineer

    Atomic North • rajkot, gujarat, in
    Job Title : Senior Quality Engineer.Shift Timing : 5 : 30 PM – 2 : 30 AM IST.Excellent Coomunication Skills • •.We are seeking a highly skilled and experienced QA Engineer to join our dynamic team.The idea...Show more
    Last updated: 3 days ago • Promoted
    Quality Assurance Auditor

    Quality Assurance Auditor

    K3-Innovations, Inc. • Rajkot, IN
    Job Title : Clinical Quality Compliance Manager.Location : Bengaluru, Karnataka, India.QA / Compliance Director or Clinical Operations Director. Clinical Site Auditor to ensure compliance and quality at...Show more
    Last updated: 30+ days ago • Promoted
    Food Safety Manager [T500-21551]

    Food Safety Manager [T500-21551]

    Inspire • Rajkot, IN
    Inspire Brands is disrupting the restaurant industry through digital transformation and operational efficiencies.The company’s technology hub, Inspire Brands Hyderabad Support Center, India, will l...Show more
    Last updated: 9 hours ago • Promoted • New!
    AGM / DGM - Biomedical Purchase

    AGM / DGM - Biomedical Purchase

    Kauvery Hospital • Rajkot, IN
    The Assistant General Manager (AGM) of Biomedical Purchase is responsible for leading and managing the end-to-end procurement process for biomedical equipment and supplies, ensuring quality, cost-e...Show more
    Last updated: 9 hours ago • Promoted • New!
    Senior Quality Engineer

    Senior Quality Engineer

    HiroJet • Rajkot, IN
    Job Title : Quality Assurance Engineer (SIEM / SaaS experience preferred).It is an early-stage cybersecurity startup building a next-generation platform for security data analytics.We process and qu...Show more
    Last updated: 9 hours ago • Promoted • New!
    Quality Assurance Engineer

    Quality Assurance Engineer

    CloudEagle.ai • Rajkot, IN
    SaaS Platform for every phase of the SaaS Lifecycle.By leveraging state-of-the-art machine learning models we help enterprises to find the right software vendor, provide actionable insights on SaaS...Show more
    Last updated: 5 days ago • Promoted
    Software Quality Assurance (SQA) Engineer

    Software Quality Assurance (SQA) Engineer

    Lillia • Rajkot, IN
    We are seeking a detail-oriented and experienced SQA Engineer with 3 to 5 years of.The ideal candidate should possess a solid understanding of. QA methodologies, with strong skills in test case crea...Show more
    Last updated: 9 hours ago • Promoted • New!
    Senior Quality Assurance Automation Engineer

    Senior Quality Assurance Automation Engineer

    Concentrix • Rajkot, IN
    Title : • • Senior Automation Tester.Department : • • Software Testing.Must have a minimum of 5 years of experience in development and execution of automation test frameworks. Data-driven, Keyword-driven ...Show more
    Last updated: 18 days ago • Promoted