Site Quality Head

2 weeks ago

Guwahati, India SUN PHARMA Full time
POSITION SUMMARY

Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.

Provide leadership and direction to ensure achievement of all site accountabilities for QA, QC and Stability at site. Proactively assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at the site and track quality assurance/control metrics with site manufacturing and drive them down. Assure all time readiness of site for regulatory agency inspections\internal audits at any given point

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

Assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down.

Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and Quality systems at the site

Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies and cost effectiveness.

Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.

Facilitate harmonization and consistent implementation of Quality Systems and procedures at site, in alignment with Global Quality policies\standards.

Ensure market complaints, failures, deviations are investigated and corrective and preventive actions are implemented with adherence to timelines

Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams

Monitor industry trends/issues faced internally and identify scope for improving Site quality management and processes.

Ensure compliance to regulatory requirements on product, process and release procedures.

Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.

Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.

Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies.

Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

Science and Pharmacy Graduates or Equivalent20+ years in a pharmaceutical quality management leadership roles experience preferred. Should be in similar role currently

REQUIRED SUCCESS ATTRIBUTEKnowledge of GxP’s, cGMP and other regulatory requirements.Planning and PrioritizationCollaboration AccountabilityComplianceCustomer Service orientationSecondary Success AttributesPeople ConnectAttention to detailEmotional control Effective Communication & Problem solving

RolesAdditional responsibilities can be assigned as required.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTSIncumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.DELEGATION OF RESPONSIBILITYIn the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation – Strategic site responsibilities to higher levelDownward Delegation – Operational responsibilities to direct reports or similar job role

  • Site Quality Head

    3 weeks ago

    Guwahati, Assam, India SUN PHARMA Full time

    Job SummarySun Pharma is seeking a highly skilled Site Quality Head to lead our quality management efforts at our site. As a key member of our team, you will be responsible for ensuring the supply of high-quality, GMP-compliant products and defining operational strategy for quality system management.Key ResponsibilitiesAssess quality issues at the site and...

  • Site Quality Head

    3 weeks ago

    guwahati, India SUN PHARMA Full time

    POSITION SUMMARYEnsure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Provide leadership and...

  • Site quality head

    3 weeks ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARY Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Provide leadership and...

  • Site Quality Head

    3 weeks ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARY Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Provide leadership and...

  • Site quality head

    1 week ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARYEnsure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Provide leadership and...

  • Site Quality Head

    7 days ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARYEnsure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Provide leadership and...

  • Site Quality Head

    3 weeks ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARY Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Provide leadership...

  • Site Quality Head

    4 weeks ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARYEnsure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Provide leadership and...

  • Site Quality Head

    3 weeks ago

    guwahati, India SUN PHARMA Full time

    POSITION SUMMARY Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Provide leadership and...

  • Site Quality Head

    3 weeks ago

    Guwahati, India SUN PHARMA Full time

    POSITION SUMMARYEnsure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Provide leadership and...

  • Site Quality Head

    3 weeks ago

    guwahati, India SUN PHARMA Full time

    POSITION SUMMARYEnsure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Provide leadership and...

  • Site Quality Director

    6 days ago

    Guwahati, Assam, India SUN PHARMA Full time

    Job DescriptionJob Title: Site Quality HeadJob Summary:As a Site Quality Head at Sun Pharma, you will be responsible for ensuring the supply of high-quality, GMP-compliant products and defining the operational strategy for quality system management at the site. You will finalize site quality assurance and control goals, objectives, and strategies in line...

  • Technical Training Academy Head

    4 months ago

    Guwahati, India SUN PHARMA Full time

    Sun Pharma is proud to announce the establishment of our  world-class  Technical Training Academies , a pioneering initiative in our industry. We invite passionate individuals with a zeal for coaching, and training to join us in this transformative journey. Seize this opportunity to  enhance your career  and shape the future of our organization. ...

  • Site Supervisor

    5 months ago

    Guwahati, India Maa Tripureswari Agency Full time

    Oversee day to day operations of the Site - Understanding client requirements and interfacing between client and departments within the organization. - To understand the technical requirements of the work and be able to explain the same to others - Provide positive direction to motivate and implement quality performance - Set project goals and oversee...

  • Manager 1

    5 months ago

    Guwahati, India SUN PHARMA Full time

    Sr. No. Responsibilities 1. To facilitate harmonize and consistent implementation of Quality System and procedures at site alignment with Corporate Quality Policies/Procedures. 2. To review documents pertaining to QMS & Compliance. 3. Responsible for ensuring compliance of Quality Management System. 4. To attend Site Training...

  • Site Surveyor

    5 months ago

    Dispur, Guwahati, Assam, India Industrial Systems LLP Full time

    Hi, We are pleased to introduce ourselves as one of the leading Turnkey Project executors of North East and are supplying Electrical & Mechanical items for the past 20 years. We are also established Class-I Contractor for all types of Electrical & Mechanical works and we have been accredited with ISO: 9001-2015 certification. We are consistent contractor/...

  • Senior Quality Assurance Manager

    2 weeks ago

    Guwahati, Assam, India SUN PHARMA Full time

    Job Summary:SUN PHARMA seeks a comprehensive Quality Assurance Manager to lead and direct quality management activities at the site, ensuring compliance with regulatory requirements and GMP standards. The ideal candidate will possess a strong background in quality management, excellent leadership skills, and the ability to drive quality improvements across...

  • Senior OSD Manufacturing Training Lead

    2 weeks ago

    Guwahati, Assam, India SUN PHARMA Full time

    Transform your career and shape the future of SUN PHARMA by joining our world-class Technical Training Academies. As a pioneer in our industry, we invite passionate individuals with a zeal for coaching and training to embark on this transformative journey.Our Technical Training Academies offer a unique platform to nurture your passion for coaching and impact...

  • Site Supervisor

    5 months ago

    Ulubari, Guwahati, Assam, India Vinayak Honda Full time

    **Company Description** Welcome to Vinayak Sales Corporation. We are seeking a dynamic and results-driven individual to join our team as a Site Supervisor for our Vinayak Honda. This role is pivotal in achieving and exceeding our sales targets while providing exceptional customer service. Qualifications And Skills Proven experience as a Site Foreman or...

  • Construction Site Supervisor

    5 months ago

    Fatasil Ambari, Guwahati, Assam, India RIDHI SIDHI INFRACON PVT LTD Full time

    A PERSON HAVING GOOD MANAGEMENT QUALITY AND SUPERVIOSION TO GET WORK DONE BY ON SITE WORKER AT TIME EFFICENTLY AND EFFECTIVELY **Salary**: ₹10,000.00 - ₹20,000.00 per month **Benefits**: - Provident Fund Schedule: - Day shift Work Location: In person