GSK - Manager - External Supply Technical Aspects - Process Technology

- Are you energized by a Process Technology role that allows you to manage and deliver the Oral Solid, Liquid, Cream & Ointment 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- Responsible for the technical aspects of product quality and knowledge transfer.

- Recognized as the principal point of contact for technical aspects of a product to drive discussions at PTC with minimal support from Technical Lead. To be the Technical Person for PTC.

- Actively facilitate the improvement of process capability, product quality and batch yields across the supply chain.

- Ensure day to day technical issues are resolved urgently to minimize reject/waste levels. Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.

- Responsible for acquiring and maintaining product knowledge expertise, and knowledge management of products throughout lifecycle. Promote and monitor technical standards throughout the product stream and ensure they are adhered to.

- Responsible for ensuring appropriate systems to track, trend and analyze product performance are in place. Responsible for applying product performance targets to products.

- Responsible for the technical aspects of new product introduction to hand over to production.

- Responsible for supporting the product transfers to sister GMS sites and third-party contract manufacturers.

- Responsible for approving and resourcing technical aspects of planned changes for launched products through effective risk management processes.

- Responsible for providing technical leadership into complex launched product performance investigations. Support the introduction of highly capable new process technologies and improvement of process capability of existing unit processes. Provide technical packaging support in response to site LICs & PIRCs, Quality notifications, CAPAs and internal audit findings

- Responsible for ensuring all aspects of Product 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.

- PLM Embed & Grow - For PLM change agent at site, TRA L2 accreditation is highly desirable. The change agent shall be active in learning and mentoring learners at the site level on the standard PLM practices, tools and techniques. PLM change agent must support other team members for achieving TRA L1 accreditation.

- Participate in the PLM COPs or other PLM forums. Effectively translate the global PLM requirements and strategy to the site level. Deploy standard PPA tools for Continuous Process Verification.

- Lead first line and second line review for PPA. Effectively engage central statistics resources for data interpretation and decision making for requirement of PLM intervention. 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. 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.

- 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. May provide leadership to others, such as Technologist roles at site, and maintains a matrix reporting relationship to the central and regional Technical groups.

- Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations. Provides technical input to annual reports, Periodic Product Reviews and internal and external audits.

- Identifies, develops and trains successors for the role, and coaches others in his/her area of expertise, ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles

Why you?

Basic Qualifications:

- We are looking for professionals with these required skills to achieve our goals:

- MS (Pharmaceutics) or M. Pharm. (Pharmaceutics) with minimum 10 years of experience specializing Manufacturing/Filling/Packaging in the Pharmaceutical/FMCG. Scientific, Technical

- 5 or more years of experience in packaging

- 2 or more years of experience in pharmaceutical packaging

- Experience with packaging component materials and processes (foils, plastics, glass, board, varnish, glues, inks, etc.)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

- Ph.D. with minimum 5 years of experience in the field of pharmaceutical industry specializing Manufacturing/Filling/Packaging in the Pharmaceutical/FMCG. Scientific, Technical

- Demonstrated ability to work effectively across a diverse customer base

- Awareness of FDA, US Pharma and Good Manufacturing Practices (GMP) requirements related to packaging

- Ability to work effectively in a matrix organisation across geographies and cultures

Other Job-Related Skills/Background :

- Project 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 level

- Time management skills, ability to manage conflicting priorities,Detailed knowledge of operational excellence tools e.g. FMEA, MSA, etc.

- Demonstrated problem solving and decision-making skills

- Strong communication, negotiating and influencing skills, Strong numeracy, literacy, analytical skills, including technical report writing

- Knowledge of execution of NPI/technical trials

- Knowledge of process validation requirements

- Experience of process validation, scale-up and technical transfer

- Detailed 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 Facilitator 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.

Note: For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.