Assistant Manager - OQ
GSK
Sindh
9d ago

Your Responsibilities : Job Purpose :

Job Purpose :

Ensure Quality Assurance processes are implemented and used in Manufacturing and Quality Operations to support producing quality products with respect to GSK and Regulatory specifications and bring improvement to make the processes more robust.

Key Responsibilities :

  • Perform in-process control checks for all areas of Lactam and Non Lactam production as required
  • Compile and review batch documents for product release
  • To handle deviations as Deviation process owner.
  • To update and maintain deviation tracker and ensure actions are completed on time.
  • To support in investigations triggered by deviations, customer complaints, online vendor complaints, self-inspections, audits and other areas as and when required.
  • To support OQ and site functions in preparation of CAPAs.
  • Review site GMS functions SOPs as required.
  • Participate in internal GMP audits.
  • Collect and compile data for Periodic Product Reviews (PPR) as required.
  • Prepare and update SOPs related to OQ activities as assigned.
  • Conduct and participate in GMP / JFT training session, GMP Talks.
  • Handle regulatory affairs as and when required.
  • Ensure system and products are in compliance with GMP regulations.
  • Update and issue site KPIs and dashboard data.
  • Participate in GAP analysis sessions of GQPs / GQMPs.
  • To ensure that EHS practices are being maintained.
  • Reporting EHS adverse events and ensure their closures
  • Manage batch record rooms and ensure proper storage, archiving and traceability of the documents.
  • Handle Customer complaints and investigate to identify the root cause and prepare CAPA as per identified root cause.
  • Assist OQ Manager to complete departmental tasks and fulfill job requirements.
  • To keep OQ department ready for audit readiness.
  • Support Operational Quality Manager for implementing and maintaining GPS.
  • Basic qualifications :

    B-Pharm / Pharm-D or M.Sc.

    Preferred qualifications :

    B-Pharm / Pharm-D or M.Sc.

    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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