Job Purpose
The job exists within the Commercial Business Unit for Pakistan - Pharma to ensure that the mandated Quality Management Systems and Local Regulatory requirements for LOC are met.
Education, Experience & Skills
- Science Graduate preferably Pharm -D
- 3 Years of Experience specially in pharmaceuticals.
- Strong understanding of industry specific technical concepts relevant to the role.
- Familiarity with GxP guidelines, ensuring compliance in regulated environment.
- Awareness of drug laws regulations, and compliance requirements applicable to the industry.
Key Responsibilities
- Support in the creation and implementation of the Quality Improvement Plan aligned with regional objectives for Pakistan in liaison with LOC Quality Manager.
- Contribute to the preparation of the Quality Councils and scribing meeting minutes for Pakistan LOC in liaison with LOC Quality Manager.
- Managing Management Monitoring system; responsible for agreeing/defining Management Monitoring universe, maintaining schedule, conducting inspection runs, writing MM reports and following up on CAPA implementation.
- Perform and manage Internal Audit System, responsible for defining internal audit universe, maintaining schedule, conducting audit runs and writing audit reports for all functions within LOC affecting product quality
- Customer Complaint Handler within Pakistan market, responsible for communicating with complainants to ensure data and sample gathering, liaising with Manufacturing Sites to conduct investigations and provide the appropriate feedback to the complainant. Also responsible for reviewing and analyzing complaint performance trending and liaising with manufacturing sites to work on the repeated issues.
- Support in Incidents and Recalls Systems Management within Pakistan LOC in liaison with LOC Quality Manager, responsible for holding LIC/PIRC, conducting investigations to determine root cause, assessing the impacted products disposition, and ensuring the carry out of effective recalls whenever needed.
- Release of Finished goods in Pakistan LOC, responsible for quality release of all imported products.
- Review and approve overprinting and repacking activities
- Technical Terms of Supply System owner within Pakistan LOC, responsible for setting and updating TTS between GSK supplying sites and LOCs to ensure the compliance of the distribution process with all regulatory requirements.
- Setting Quality Agreements between Pakistan LOC and third-party manufacturing sites, service providers and distributors.
- Conducting audits of Third parties in liaison with Consumer to ensure compliance of storage and distribution of GSK products, also responsible for the effective oversight related to Good Distribution Practice and KPIs
- Regulatory Inspection Management, responsible for preparing LOC Quality for any regulatory inspection to ensure all regulatory/GXP requirements are fulfilled.
- Reference Standard Managment for Imported Products.
- Regulatory Inspection Management, responsible for preparing LOC Quality for any regulatory inspection to ensure all regulatory/GXP requirements are fulfilled.
- QMS training Management for LOC staff as required in MyLearning and Conduct QMS trainings to Relevant stakeholders as required.
- Working location would be hybrid model as 2-3 days from contract warehouse per week depending on requirement where overprinting operations and warehousing oversight need to be performed for QA role.
- Role includes provision of pharmacy registration for import license for imported goods in Pakistan,
Deputized Responsibilities:
- QMS Champion within Pakistan LOC, supporting QMS implementation.
- Assigning GAP Analysis teams and following up to ensure completion within due dates.
- For new generation QMS; Adoption of newly issued PGSOPs in the local SOP system within due dates.
- Ensure the risk areas in relation to QMS activities within the LOC are identified and the risks are appropriately assessed and escalated to local/regional Quality Council meetings and RMCB as required; as well as proper development and follow-up of mitigation plan(s).
- Following up on Quality KPIs for Pakistan LOC to ensure that Quality targets are met & any improvement plans are developed.
- Attending Regional Quality Council meetings and support in preparation as required.
- CAPA System Management within Pakistan LOC, responsible for CAPA plan development, agreement and follow-up, document closure evidence and escalate CAPAs that are not completed within the agreed dates to ensure effective closure of all CAPAs.
- Quality Regulatory Intelligence Management within Pakistan LOC, ensuring the compliance with the up-to-date regulatory requirements and that the LOCs are informed of relevant developments and trends, by performing assessment for any received QRI and assigning CAPA plan to close any gaps and conducting QRI quarterly committee in liaison with GMS sites.
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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