Assistant Manager - Validation
Karachi Pakistan
5d ago

Job Purpose

To ensure compliance with local regulatory requirements and QMS related to validation by managing & performing validation studies of facility, utilities, equipment, laboratories, computerized systems and processes that have an impact on the quality of GMP regulated products and building quality into all quality critical systems.

Educational and Experience Requirements :

Minimum Level of Education

M.Sc. / B. Pharm. / Pharm D

Area of Specialisation*

Pharmacy, Chemistry, Microbiology.

Minimum Level of Job-Related Experience required

6 to 9 years

Need experience of QMS / Technical / Validation / Production

Following knowledge is required at this position :

  • Overall knowledge of Site Operations. Knowledge of Site Manufacturing, Ware house, Engineering and Utility Operations and their Contribution in Site Role.
  • Experience to functional role of Quality.
  • Knowledge of Yearly Site Targets in terms of KPI’s
  • Deviation Handling
  • Sound knowledge of the Quality Management System
  • Thorough understanding of cGMP.
  • Experience to handle the regulatory inspections.
  • Knowledge of Lab. Operation work flow and its alignment with OQ to facilitate fast Product releases.
  • Knowledge of GSK Commissioning & Qualification System (CQS).
  • An understanding of the drug development and manufacturing processes employed in the pharmaceutical industry. Breadth & depth across disciplines or functions;
  • expertise in field required

    Key Responsibilities

  • To ensure all facilities equipment and operations at site are validated (DQ, IQ, OQ, PQ) in line with regulatory and corporate requirements.
  • To provide validation support to the continuous improvement automation of corporate projects in an environment of rapid change
  • To coordinate / complete validation of new non-lactam sterile project within defined timeline.
  • To coordinate with multi-functional validation working party (VWP) in achieving validation targets as per defined time lines.
  • To prepare data for update of validation activities for site Quality Council Meeting
  • Site Validation Master Plan

  • Creating and maintaining Site Validation Master Plan (SVMP) in compliance with the group quality policies and regulatory requirements.
  • Creating and maintaining VMPs as appropriate for new projects such as upgrades to facilities, new product induction
  • Coordinate with engineering department in order to ensure availability of DQ, IQ, and OQ.
  • Performance Qualification Protocols :

  • Creating / facilitating validation protocols which fulfill current compliance requirements
  • Consulting with production, quality function, stores and engineering
  • Managing changes to validation protocols
  • Continuous improvement, periodic review and collaborating with user departments and support groups
  • Preparation of Validation summary reports to meet customers and release deadlines.
  • Cleaning Validation and Verification :

  • Validation of cleaning procedures of production related equipment
  • Preparation of cleaning validation protocols for new manufacturing and filling equipment and or to incorporate changes or products.
  • Preparation of cleaning verification protocol for non-routine production activities.
  • Coordinate to carry out cleaning validation exercise with Planning, Production and Lab Operations.
  • Periodic Reviews :

  • Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status.
  • Audit Readiness :

  • Being ready for audit all the time.
  • Ensuring that all the validation documentation is complete, accurate and accessible.
  • Participating in audit preparation and related training
  • Manufacturing of trial / experimental batches :

  • Time to time monitoring of trial / experimental batches being manufactured at site and ensure compliance.
  • Training :

  • Ensure that the trainings on validation related SOPs have been delivered in time to all the stakes holders.
  • To ensure that all the SOPs related to Validation department are in place and in use.
  • QMS Implementation :

  • To keep Validation department in line with the GOPs and GQMPs related to Validation.
  • To Participate in GAP analysis session related to Validation

    Sterile Non-Lactam Project

  • To prepare VMP of Non-Lactam sterile project
  • To conduct VWP sterile project meeting in regular basis
  • To follow up validation status of DQ / IQ / OQ / PQ status
  • To participate in PQ of sterile area equipment
  • To prepare volition protocol / reports of product validation and cleaning validation of equipment.
  • Coordonnées :

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