As a Compliance Officer, you will 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
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
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 E-QMS 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 QA-Compliance department.
- Execute & coordinate with site departments for lighten-up 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 lighten-up process.
- Involve in self-inspections, 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.
- On time complete training curricula assigned in My-Learning or QMS training and provide the training to the staff where it is required.
- Follow up for completion of Quality Agreements & Quality Alerts responses.
- Promote safe-working environment that complies with company EHS requirements.
- Following and sustaining GPS standards in QA Compliance Department. Adhere to quality KPIs within the department.
- To undergo training in GQPs and PGSOPs on Effective QMS Implementation.
- To notify operational managers, technical experts and other impacted target groups of new or revised QMS documents.
- To identify resource capable of performing gap analyses between site/LOC or global function SOPs, standards, facilities, or systems and the QMS updates.
- To ensure training needs are assessed for target groups and training plans prepared in advance of receipt of new or revised QMS documents
- Adhere to Safety, Quality and GPS standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect and Zero Waste for continues improvements.
- Maintain site Standard Operating Procedures (SOPs) system
- To support the deployment and adherence of Data Integrity Program at site and integration of Audit System / QMS with RMS system.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree of science or Pharmacy
- Two (2) 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).
- Master’s degree is a Plus
Closing date:
13/11/2024
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, it’s 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:
You may apply for this position online by selecting the Apply now button.
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