MSAT Product Owner

GlaxoSmithKline; Indi; Hybrid; INR 1,500,000 - 2,500,000; Full time

Job summary

GlaxoSmithKline is seeking a Technical Product Owner to manage the Solid oral, Liquids, sterile and topical dosage portfolios, including new product introductions and complex changes across sites.

The role requires leading investigations, risk assessments and cross-functional collaboration to ensure product quality and robust performance throughout the lifecycle. Strong data analysis and GMP knowledge are essential.

Qualifications

• Educational background as stated: M. Pharm. (Pharmaceutics) with up to 5 years of experience.
• Experience leading technical product lifecycle activities including technology transfers and risk assessments.
• Strong knowledge of GMP and product quality requirements; ability to work across functions/sites.

Responsibilities

• Lead new product introductions, technology transfers, scale-up, validation, and handover to manufacturing.
• Own product technical knowledge, process capability, robustness and verification.
• Collaborate across Quality, Operations, Engineering, R&D, suppliers, and global sites to strengthen technical capabilities.

Skills

Technical leadership

Project management

Data analysis

Statistical tools

GxP compliance

Risk assessment (FMEA)

Education

M. Pharm. (Pharmaceutics)

Tools

MSAT

QbD

DOE

Process validation

Job description

Job Title - Technical Product OwnerLocation - Baddi - #LI-RemoteJob PurposeTo manage and deliver the Solid oral, Liquids, sterile and topical dosage product portfolio, including new product introduction, and complex changes to existing products, input materials, processes, equipment technologies and manufacturing sites to meet business demands.To ‘own’ and provide technical leadership for a product or product family at a local (site) and/or global level (across all sites where the product is manufactured), and to ensure that the product is delivered to the highest levels of quality and robustness.To support PLM lead to ensure a successful PLM implementation & sustainability. Support on statistical analysis and statistical capability building in ES India.Key ResponsibilitiesServe as the Technical Product Owner , throughout the product lifecycle.Lead new product introductions, technology transfers, scale-up, validation, and handover to manufacturing sites and contract partners.Own product technical knowledge, performance monitoring, process capability, robustness, and continuous process verification.Assess and approve technical changes using risk management tools, ensuring product control strategies and mitigation plans remain current.Lead investigations and root-cause analysis for deviations, complaints, CAPAs, audit findings, and complex product-performance issues.Prepare and review technical documentation, including risk assessments, specifications, validation reports, qualification documents, and periodic product reviews.Collaborate across Quality, Operations, Engineering, R&D, suppliers, and global sites while coaching teams and strengthening technical and statistical capabilities. Knowledge/ Education / Experience RequiredA. Educational BackgroundMinimum Level of EducationM. Pharm. (Pharmaceutics) with up to 5 years of experienceArea of SpecialisationPharmaceutical manufacturing, technical operations, MSAT or product ownership.Experience in new product introduction, technology transfer or lifecycle management.Proven ability to lead technical investigations, root cause analysis and implement corrective actions.Why is this Level of Education Required?To give the necessary level of knowledge and understanding to be able to lead a technical team in delivering new product introductions and complex changes.To demonstrate the appropriate level of scientific and technical understanding.Good communication skills in English and ability to work across functions and sites.B. Job-Related ExperienceMinimum Level of Job-Related Experience requiredDemonstrated experience in the pharmaceutical industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, validation and change control.Knowledge of Good Manufacturing Practices (GMP) and strong understanding of product quality requirementsProven capability to lead teams, both line and matrix, in a Technical role.Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality requirementsIn depth knowledge and understanding of product dosage forms and their manufacturing processes.Familiarity with data analysis, statistical tools or digital product lifecycle tools.Why is this Level of Experience Required?To give the necessary level of knowledge and understanding to be able to lead a technical team to deliver new product introductions and complex changes.In order to effectively and independently own and lead all elements of the Product Lifecycle for a specific product or product family.Experience working in a matrix organisation across geographies and cultures.Strong stakeholder management and supplier collaboration skills.C. Other Job-Related Skills/BackgroundProject management skills and experience on major technical projects, Resource management.Ability to use and interpret data to drive decision making at both tactical and strategic levelTime management skills, ability to manage conflicting prioritiesDetailed knowledge of operational excellence tools e.g. FMEA, MSA, etc.Demonstrated problem solving and decision-making skillsStrong communication, negotiating and influencing skillsExperience with packaging components, primary containers or device qualification.Experience in sterile products, liquids, solids or topical dosage forms.Experience with validation protocols, qualification activities and risk assessments (FMEA, TRA).Familiarity with data analysis, statistical tools or digital product lifecycle tools.Strong numeracy, literacy, analytical skills, including technical report writingKnowledge of execution of NPI/technical trialsKnowledge of process validation requirementsExperience of process validation, scale-up and technical transferDetailed knowledge of relevant dosage form including: unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallization, isolation, drying and particle size reduction), plant equipment and analytical testing. Awareness of device/packaging processes.Level 1 Practitioner for TRAs (‘Proficient’ level as defined by the TRA competency framework)The recommendation is for an L1 Capable or Accredited TRA Facilitator to serve as the site level PLM Change Agent or someone that has a good understanding of the PLM toolsets and how they work to bring benefit to the site.Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).Knowledge of regulatory environment, particularly in markets where product is commercialized.Track record of improving products, processes and trouble-shooting, execution of technical activities including trials and validation activities.Experienced in technology transfer, with an understanding of the product development process.Thorough knowledge of GMP and EHS requirements.Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA.Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders.SkillsCMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology TransferWhy 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 [e-mail] to discuss your needs.Important notice to Employment businesses/ AgenciesGSK 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. 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