QMS Champion
GSK
Karachi
13d ago

Your Responsibilities : Role Purpose :

Role Purpose :

Ensure Quality Management Systems are integrated into site’s processes and procedure through Gap Analysis processes in order to ensure Quality Assurance to support producing quality products with respect to QMS, GMP and Regulatory Compliance

Key Responsibilities : QMS IMPLEMENTATION

QMS IMPLEMENTATION

  • Ensure compliance of QMS and Regulatory requirements.
  • Ensure that Gap analysis of GQPs / GQMPs is conducted against existing site SOPs and practices
  • Ensure that action plan for the identified gaps in the relevant gap sheets is prepared
  • Follow-up for the timely closure of the identified gaps.
  • Provide update QMS / training KPIs for Quality dashboard
  • Identify, document and manage risks associated with QMS gaps.
  • Carry out In-place In-use reviews of Quality systems.
  • Keep an update of new and revised QMS requirements. Assist the same for managing product,
  • regulatory compliance and business improvements.
  • Support in effective communication with departments on QMS updates / other changes.
  • Support for the fulfillment of GMP compliance and various quality requirements as per GQPs and GQMPs
  • Ensure timely updates of CARISMA regarding Quality Alerts
  • Manage Action Plans of QMS, Quality Alerts and L1 Actions through softwares like CARISMA and QWF.
  • To carry out correspondence of Regulatory related issues.
  • To handle drug samples received from Drug Regulating Authorities.
  • To ensure that EHS practices are being maintained.
  • Reporting EHS adverse events and ensure their closures
  • Support for implementing and maintaining GPS.
  • Work with zero accidents, defects and waste by committing to our fundamentals Safety
  • Identify at least five Zero Accident Promotion to meet target i.e. five reports per employee in 2017.
  • Actively participate in safety and health related events and improve the working conditions.
  • Basic qualifications :

    B-Pharm / Pharm-D or M.Sc. (Preferably specialization in Pharmacy, Applied Chemistry, Chemistry, Microbiology)

    Preferred qualifications :

    B-Pharm / Pharm-D or M.Sc. (Preferably specialization in Pharmacy, Applied Chemistry, Chemistry, Microbiology)

    Why GSK? :

    At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-

    leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy.

    To achieve this, we strive to attract the best people and to create an environment that empowers and inspires

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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