Compliance Officer - GSK

Job Purpose

To perform quality critical activities in Quality Compliance department which will help ensuring that all activities are undertaken following the appropriate Regulatory (SFDA) guidelines GMP standards QMS requirements & relevant local standard operating procedures.

Key Responsibilities

• Review communicate update and maintain the assigned Technical Terms of Supply.
• Perform Periodic Product Review on annual basis as per approved schedule & trending process. Track adherence to schedule for timely completion without any overdue PPR.
• Keep all tracks & record of SFDA guideline gap analysis.
• Responsible for maintaining Site EQMS Workflows keep tracking of all actions for their timely closure & escalate any expected delay of closing to Compliance Manager.
• Participate in LIC & PIRC processes as & when required to support QA Compliance Manager.
• Responsible to prepare & review Standard Operating Procedure relevant to QA Compliance function.
• Responsible for site record retention activities performed on annual basis in QACompliance department. Execute & coordinate with site departments for lightenup project in Record Retention & outcome reported to Compliance Manager. Maintain the critical & highly confidential documents in the Document Archive Room under safe custody without any damage or deterioration with easy traceability.
• Review archived quality critical documents on routine basis to carry in their destruction process which has passed their retention period & keep the record of destruction for reporting in lightenup process.
• Involve in selfinspections internal audits (IBM) and Regulatory audits to support Compliance Manager.
• Identify departmental quality risks and escalate to the Compliance Manager.
• Involve in QMS gap analysis as a reviewer to identify gaps pertaining to Compliance function.

Key Requirements:

• Graduate Bachelor of Science or Pharmacy from a recognized institution.
• Two (02) Years experience in a pharmaceutical environment. Expertise in the field of quality.
• Good knowledge of GMP GDP & EHS.
• Good level of English language. Written & spoken
• Experience of production processes equipment and systems.
• Good documentation ability.
• Competency level Competent
• Good in Computer skills (Microsoft office).

Closing Date: 29/05/2024

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.

Contact information:

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