MSAT Drug Product Owner
Job Description
Job Title - MSAT Drug Product Owner
Location - Baddi (Himachal Pradesh) - #LI-Remote
Job Purpose:
To provide technical support to Drug Product portfolio like Solid Oral Dose, Liquids, Creams, Ointments and Sterile. To work closely with Cross functional teams to ensure safe, compliant, and efficient product operations. The role involves managing all technical aspects of the product and product family, including New product development, Line extensions, Product transfers, Technology transfers, Troubleshooting, Continuous improvement initiatives, Source changes, Investigations, Routine site support and Product lifecycle management (PLM) activities.
Key Responsibilities:
- To provide technical support for Development work, Transfers, Routine site supports, Improvement initiatives, Source changes & Material risk assessments (MRA), Trouble shooting and Investigations.
- To acquire and maintain product and process knowledge, effective Product Lifecycle Management (PLM) with Technical Risk Assessments (TRA), Product Control Strategies (PCS), Continued Process Verification (CPV).
- Product performance monitoring with statistical and digital tools. Risk assessments and mitigation plans.
- To provide technical support for documentation including MFR, MPR, SOP, PPR/APQR, Change controls, Deviations.
- Participate actively in different Validation activities.
- Ability to make different presentations with technical data base for project and outcome approvals from local and global teams.
Knowledge/ Education / Experience Required:
Educational Background (Minimum Level of Education):
M. Pharm. (Pharmaceutics) or MS (Pharmaceutical sciences) with 3 to 12 years of experience
OR
Ph. D. with minimum 2 to 7 years of experience in the field of pharmaceutical industry.
Minimum Level of Job-Related Experience required:
- Pharmaceutical experience on dose forms like Solid Oral Dose, Liquids, Creams, Ointments and Sterile.
- In depth knowledge and understanding of product dose forms and their manufacturing processes.
- Knowledge of cGMP, regulatory requirements, QMS.
- Knowledge of Statistical and Digital Tools.
- Proven capability to work with cross functional teams and drive the projects.
- Strong academic and Industrial expertise to give the necessary level of knowledge and understanding to be able to lead / drive various projects.
- Effective communications and leadership abilities.
Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at [email protected] to discuss your needs.
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