Validation and Pack Management Lead
Karachi Pakistan
3d ago

Job Purpose

To ensure GSK West wharf Site in compliance with regulatory and GSK requirements on Validation studies and CSV by performing and providing expertise and leadership in the implementation of GSK policies, standards and building quality into all systems & also Release of good quality packaging material as per GSK standards.

Educational Requirements

Minimum Level of Job-Related Experience required

5 to 10 years

Needs to have Team Leadership Skills

Stakeholder Management Skills

Communication Skills

Validation & Sterile Experience Required

Minimum Level of Education

B.Pharm / Pharm.D / Msc

Area of Specialisation

Must have knowledge of sterile operations

Knowledge of working in Lactam / Non Lactram

Quality, Production, Engineering, Validations, process & Packaging processes

Key Responsibilities

Pack Management Manager :

  • Checking of artworks, bromides, machine proof, & buying samples as per standards and regulatory requirements with respect to formulation RN & ML Nos.
  • Storage conditions& Address to ensure GSK requirements are met and to avoid any Regulatory sanctions

  • Finally to check the total artwork after the input of concerned Departments so that all the requirements are fulfilled in the Artworks.
  • Conduct L1, audits to ensure compliance,
  • Meeting with Supplier’s for on-line complaint and rejections in order to facilitate the supplier in CAPA so to avoid recurrence in future supplies
  • Preparation of monthly report of the section, Vendor complaints & rejection data for supply review meetings.
  • Preparation / Review of specifications / test methods, SOP’s of packaging material to ensure compliance
  • Conduct training on revised specifications / test methods, SOPs to develop staff
  • Update the QMS& training records to ensure compliance
  • To manage calibration, EHS, artwork control, change control & documentation related activities, to ensure compliance.
  • Site Validation Manager :

  • Ensure all facilities, equipments and operations at site are validated (DQ, IQ, OQ, PQ) in line with the regulatory and corporate requirements.
  • Facilitating and providing support to the continuous improvement and automation projects in an environment of rapid change.
  • Working in cross-functional teams responsible for process improvement and process compliance; bringing the regulatory and corporate perspective of validation and systems applications to the GMS
  • Ensure and support the validation team party in achieving validation targets as per defined time lines
  • To present the status or update of validation activities in the Site Quality Councils meeting
  • Site Validation Master Plan and Validation Master Plans :

  • Ensure the SVMPs and VMPs is inplace in compliance with the GQPs, GQMPs and regulatory requirements.
  • Ensure to maintain SVMPs and VMPs as appropriate for new projects such as upgradation to facilities, systems and new product introduction etc at Site.
  • Performance Qualification Protocols :

  • Ensure that the validation protocols fulfill current compliance requirements and validation activities will be carried out in Consulting with Production, Quality function, Warehouse and Engineering.
  • Ensure that the Validation Summary Reports must be prepared on time to meet customer and release deadlines.
  • Cleaning Validation and Verification :

  • Ensure that the cleaning validation & verification activities will be carried out timely with all related documents inplace.
  • Ensure that the monitoring of cleaning validation program is annually.
  • Ensure the revalidation of manufacturing and filling cleaning processes (where required).
  • Periodic Reviews :

  • Ensure the periodically reviews of validated manufacturing and filling processes, equipments, utilities, facilities, cleaning processes in order to ensure that they remain in validated status.
  • Solutions to on-going production issues :

  • Participating and liaising with other departments in investigations and providing expertise in various areas of production
  • Process improvement :

  • Evaluating new ideas based on their ability to minimize rejects and increase efficiency of the process
  • Trial / experimental batches :

  • Ensure that the trial / experimental / Reworking / reworking batches are monitored
  • Implement procedures of CSV as a Site CSV Lead
  • Audits :

  • To ensure Level-1,Level-2,Level3 and Level-4 audit compliance
  • Ensure that the Level-1 audits are carried out as per time line
  • To ensure that the all the SOPs related to validation are in place and in-use
  • Maintains a safe and healthy work environment :

  • Ensure implementation of EHS standards and guidelines in the area of responsibility.
  • Reporting EHS adverse events (Near misses, Incidents and Accidents) timely.
  • Coordonnées :

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