Site Change Control & DI Lead

at GSK
Location Karachi, Pakistan
Date Posted January 30, 2021
Category Pharmaceutical
Job Type Full-time
Education Requirement Bachelors/Masters
Career Level Mid Level
Experience Experienced
Base Salary Competitive Salary
Street address Karachi

Description

Site Name: Pakistan - Sindh - Karachi
Posted Date: Jan 29 2021

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, the GSK Quality function could be an ideal opportunity to explore.

Job Purpose

This role is accountable for oversight of the Change Control Process at a site, ensuring that all planned changes relating to GMP activities are Controlled in order to assure the Quality, Safety and efficacy of GSK materials and products and ensure compliance with legal and regulatory requirements. Perform OQ oversight including in process at production floor.

Minimum Level of Education

B. Pharm /Pharm-D /Science Masters/ Bachelor Degree with experience of 3-5 Years in the function

Area of Specialisation

Pharmaceuticals, Chemistry, Management /Health sciences

Skills Required

Analytical Skills, Proactive approach, Team building, Presentation skills, Analytically Sound, Knowledge of Pharmaceutical dosage forms, Writing and verbal communication skills in English.

Key Responsibilities

  • Ensure products are manufactured with respect to GSK specifications during manufacturing process
  • Develop a Quality mindset across manufacturing functions to ensure CGMP in Production and achieving Quality Products.
  • Manage Operational Quality Key objectives and routine tasks for timely completion as per GSK requirements to ensure smooth function in the department.

Change Control expert who ensures full deployment of GSK’s Quality management system for Change control, ensuring requirements are both in place and in use, including development of appropriate KPI’s and monitoring of these through governance process.

  • Coordinates the evaluation of all changes with potential impact on product Quality, GMP or regulatory Compliance at site level. Reviews and approve change control Requests/Assessment from the Quality standpoint, as a designate of Operational Quality manager
  • Ensure that the Change control evaluation is appropriate to achieve the desired result and does not include the Quality risks or potential issues elsewhere (Including within site or Supply chain)
  • Ensures there is an assessment, justification and documentation of the tasks, data and acceptance criteria that will be required to support and verify the change e.g. stability, revalidation, training. Ensures there are consideration for a review of the cumulative effects of implemented changes.
  • Coordinate meetings/Panels for multi-functional team decisions of change control, ensuring there is expertise above -site sought as necessary.
  • Responsible for identification of roles and responsibilities for review, approval and implementation of each aspect of change as well as the type of change, subject to change control that have the potential to impact GMP, the quality, safety, efficacy or stability of products, regulatory compliance and the validation status of processes, facilities and systems.
  • Take into account the wider requirements of the supply chain for generation and provision of supporting data for the Change control assessment.
  • Monitor preparation for change control implementation, once change control has been given formal approval to implement into manufacture to ensure remaining actions and activities are completed prior to embedding the change into routine use. (e.g. updation of batch documentation, drawings completion of trainings.)
  • Communicate all the relevant parties the decision /date for implementation and either close the change or, if applicable, monitor post implementation activities. Ensure that any post implementation activities are carried out in a timely manner and documented appropriately.
  • Ensure change control process and decisions are well connected and considered as inputs/outputs to the periodic Product review, Documentation change control, Engineering change handling, validations ,Batch release process.
  • Liaison of the site Change control originator /Owner to link with other off site organizations, when there is a change that impacts more than one site. The change control lead will support the change control owner/originator on managing the investigational, development and qualification activities for a change which impacts more than one site. The change control lead will ensure there are communications to all the other impacted sites and the central groups e.g. Technical Centre of Excellence (s) and central Regulatory.

Other (Documents, Process Standards And Records)

  • Manage Documents such as Standard operating procedure, Change Controls, Tracker, evidences of the change control, responding to internal and external customer for information and technical requirement etc.
  • Providing monthly and weekly report.
  • Support provided in handling of deviations, Certificate of Analysis, In process Check and complaints on need basis.
  • Conducting level 1 Audit of the department and participate in the level II & level III audit.
  • Participate in conducting GAP analysis of GQP’s & GQMPs and Quality Alert sessions.
  • Prepare and review SOP’s and provide training on SOP’s.
  • OQ oversight including in process on production floor.

Contact Information

You may apply for this position online by selecting the Apply now button.

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