GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : Assistant Manager - Technologist & Product Owner
• Work as a Product Owner with support from Platform Experts to deliver the site and Technical objectives. For Product Owner at ES India, TRA L1 accreditation is highly desirable.
• Product owner shall be a key support to Technical Lead / Manager for driving technical discussions at PTC.
• Support operations in the monitoring of the manufacturing process to identify any issues and optimize / escalate where appropriate.
• Generate and monitor product quality trends and escalate issues as appropriate to regional / global Product Owners or Platform Experts. This may involve leading or participating in a larger scale investigation.
• Support delivery of Product Lifecycle Management including Technical Risk Assessments, continuous improvement of Product Control Strategies and translating Control Strategies into standard work within Operations, as per the principles of the GSK Production System (GPS).
• Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D.
• Provides technical input to annual reports, Periodic Product Reviews and internal and external audits.
Product Lifecycle Management
• Recognised as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment.
• Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards.
• Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
• Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties (primary product owner), assessment of impact of API/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), etc
• Work within New Product Introduction and ongoing supply to define the technical requirements for trials and campaigns and liaise with Logistics and Quality functions to deliver production trials. Assist in the delivery of the technical requirements for trials, such as batch documents, sample plans, data collection, tooling, testing regimes, etc. and ensure compliance during trial manufacture.
• Support technical aspects of raw material source change by conducting technical assessments to ensure safe and compliant implementation of change and continuity/security of supply.
• Provide troubleshooting support for production processes and equipments. Carry out laboratory work as necessary to assist in process improvements / manufacturing investigations.
• Provides technical leadership and input into root cause analyses to support the investigation and resolution of product issues as OOS, complaints and deviations, in conjunction with ESQ and operations.
• Support external and internal audits / inspections as required and all relevant compliance requirements.
• Provide technical packaging support in response to site LICs & PIRCs, Quality notifications, CAPAs and internal audit findings, as appropriate.
• MS (Pharmaceutics) or M. Pharm (Pharmaceutics) with 4-5 years of experience in pharmaceutical industry
• Manufacturing/Filling/Packaging in the Pharmaceutical/FMCG. Scientific, Technical
• Ph.D with minimum 0-3 years of experience in the field of pharmaceutical industry
• Knowledge of Liquid Cream Ointment Dose form and manufacturing processes.
• Project Management skills.
• Time Management skills, ability to manage conflicting priorities.
• Resource Management ability.
• Demonstrated attention to detail.
• Demonstrated problem solving and decision-making skills.
• Knowledge and understanding of analytical testing.
• Data capture, manipulation and interpretation skills.
• Knowledge or experience of using statistics; data analysis, MSA, DOE etc.
• Well organized, self-driven, able to engage well with people at all levels of the organization and build strong relationships.
• Good communication and influencing skills.
• Strong numeracy, literacy, analytical and interpersonal skills.
Location : Karnataka - Bangalore
Qualification : Ph.D, M.Sc
Req ID : 252439
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th June, 2020
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