OQ Manager
Stiefel Laboratories, Inc
Karachi, Pakistan
10d ago

Your Responsibilities : Job Purpose :

Job Purpose :

To ensure that products released for sale have been manufactured and packed in accordance with the licensing requirements, Quality Management System, Good Pharmaceutical Manufacturing Practice and business requirements, and to promote quality / compliance within their area of operations.

To ensure cGMP practices and quality standards on processes, products personnel and systems ensuring compliance to control procedures and regulations.

Support compliance of QMS requirements, Level 2 Audits and supporting Level1 audits at site. Ensure and support compliance of regulatory requirements and responsible for site compliance training.

Key Responsibilities : Product Release

Product Release

  • Provide an effective product release service which ensures that all products are released for sale or further processing have a quality appropriate to their intended use, i.
  • e. comply with Company QMS Standards and Product Quality Specifications

  • To ensure that products are released for sale according to regulatory Requirements, cGMP and business requirements.
  • To ensure Technical Terms of Supply / Quality agreement document is maintained for each imported & exported product.
  • Ensure proper compilation and review of batch dossiers.
  • Ensure that batch dossiers are retained as per local regulatory and GSK record retention policy.
  • Deviation Handling :

  • Rectifying or reporting any deviations from cGMP or the Quality Management System.
  • Providing advice to line management to ensure that cGMP compliance requirements are built into the site's core practices.
  • Ensure that SLT are notified of any trends / changes or deviations from cGMP, and are also reported to Site Quality Council.
  • Ensure that product quality issues are correctly investigated and that appropriate corrective and preventive actions are implemented.
  • Investigation Handling

  • Assess / investigate the data on products failing to meet standard
  • Ensure the timely completion of investigations and actions
  • Support in case of expanded investigation of Out of Specification results.
  • CAPA Plan Handling

  • Ensure that CAPAs are in place for any significant quality non- compliance
  • Support & Coordinate with stake holders for the CAPA preparation.
  • Change Control

  • Ensure that any change having impact on product quality is appropriately assessed through the change control process
  • Coordination with stake holders and ensure timely closure of change control.
  • Ensure that the change control acceptance criterion is developed with the consent of defined team.
  • Customer Complaints :

  • Ensure market complaints are handled effectively and timely as per standard procedures.
  • Ensure complaints are timely logged, investigated, and responded to stakeholders
  • Maintains Process Standards :

  • Ensure that manufacturing, filling and packing activities are performed according to BMR, BPR and relevant SOPs.
  • Ensure that the BMRs, BPRs, Validation Protocols &Reports, product transfer documents , SOPs and any other documents having impact on product quality are reviewed by OQ.
  • Provide OQ input to New Product Introduction / Product Transfer teams, activities pertaining to area qualification and validation batches.
  • Compliance

  • Ensure level one audits are managed according to GQMP / GQPs at Operational Quality.
  • Ensure implementation of SOPs and group policies related to Operational Quality
  • Ensure In-process checking, Line clearance during operations according to SOPs.
  • Understanding and taking actions to mitigate risks
  • Manage gap analysis sessions for GQPs and GQMPs of Quality Management System (QMS)
  • Support site for the compliance of QMS.
  • Ensure timely update of site KPIs and dashboard data and compliance of Quality KPIs.
  • Basic qualifications :

    B-Pharm / Pharm-D or M.Sc. Preferably Pharmacy, Applied Chemistry, Chemistry, Microbiology

    Preferred qualifications :

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

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