
Assistant Manager Validation
1 week ago
Site Name: Pakistan - Sindh - Karachi
Posted Date: Aug
This role is an exciting opportunity to ensure the quality and compliance of manufacturing processes at GSK Pakistan. You will play a key role in validation activities, ensuring that equipment, processes, and systems meet regulatory and quality standards. Collaboration with cross-functional teams and adherence to compliance requirements are essential. We value candidates who are detail-oriented, proactive, and committed to continuous improvement.
Responsibilities
- Plan, execute, and document validation activities for equipment, processes, and systems. To ensure all facilities, equipment and operations at site are validated (URS, DQ, IQ, OQ, PQ) in line with regulatory requirements.
- Ensure compliance with regulatory and quality standards during validation processes.
- Collaborate and with Work in cross-functional teams like Production, Quality function, Warehouse Engineering and technical to address validation needs and ensure in achieving validation targets as per defined timelines.
- Develop and review validation protocols and reports.
Monitor and maintain validated status of equipment and processes through periodic reviews. Including manufacturing and filling processes, equipment's, utilities, facilities, cleaning processes, to ensure that they remain in validated status.
Prepare and ensure to maintain SVMPs and VMPs as appropriate for new projects such as upgradation to facilities, systems, and new product introduction etc. at Site.
- Support investigations and corrective actions related to validation deviations.
- Conduct management monitoring/ IBM to ensure compliance of procedures and systems as per audit universe and timely closure of all actions and CAPAs (Management monitoring, IBM, deviations, change control, Supplier STPs, risk, complaints, DI, QIP etc.)
Qualifications/Skills
Basic:
- Bachelor's degree in pharmacy, BS (Natural Science), B.E/BSc in Engineering
- 3–5 years of experience in validation or a similar role within the pharmaceutical industry.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Strong communication and documentation skills.
- On-site role based in Pakistan.
Preferred:
- Experience with validation processes and regulatory compliance.
- Hands on experience with equipment qualification deliverables like (URS, RA,DQ, IQ, OQ, PQ).
- Experience with computerized systems validation and Excel spread sheet validation.
- Prefer to experience with commissioning and qualification activities related to pharmaceutical equipment/system with Engineering background.
- Good Knowledge of cleaning validation life cycle approach and environmental monitoring.
- Ability to work collaboratively in a team-oriented environment.
Join us in ensuring the quality and safety of our products while making a positive impact on patients' lives. We look forward to welcoming a dedicated professional to our team
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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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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