About iNova
iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.
The Opportunity
We currently have an opportunity for a Group Technical Operations Manager to join our Technical Operations team in Singapore on a 2 years’ contract basis. Reporting to the Group Technical Director, the position assumes responsibility for technical and product development areas including:
- Providing Technical Support and guidance in Product Development, Technical Transfer, & Life cycle Management projects, and support new product introduction into ANZ, South Africa, Asia Pacific region or as required by the business.
- Supporting EMO Directors by leading product and EMO operations due diligence activities, as needed
- Providing technical input in operations improvement projects, NPD and line extensions projects.
- Providing EMOs with cGMP expectations with regard to development and manufacturing validation activities.
- Ensuring that all validation activities are carried out in time with EMO’s and review and approve documents related to validation activities, including protocols and final reports.
- Troubleshooting technical problems encountered by various EMO's.
- Support the Packaging team and Marketing team with packaging selection.Supporting the preparation of CMC technical aspects of regulatory registration files for cosmetics, listed products and registered products.
Actively communicate with Supply Chain, Marketing and QA regarding product technical issues and resolve with EMO’s.
Key accountabilities and performance indicators include:
Provide Technical leadership in support of initiatives and relationships managed by the External Manufacturing Directors.
- Satisfactory delivery of support services to the External Manufacturing Directors on a project by project basis.
Support & partner Regulatory Affairs in all Technical aspects of regulatory product registration process (AUST L , AUST R, others ).
- Support preparation / review of Common Technical Document (eCTD) or Technical File in accordance with project timelines.
- Coordinate responses to all technical queries from regulatory agencies
Lead in the technical investigation of annual stability Out of Specification (OOS) investigation in collaboration.
- Provide technical input and review proposed CAPAs.
Technical support for new product and other projects in iNova Business region (iGate).
- Key member of the project teams responsible for establishing and delivering technical elements of NPD projects in line with agreed timing.
- Identifying technical risks associated with NPD projects and developing mitigations plans to resolve.
- Reviewing validation protocols & reports and providing expertise to EMO.
Project Team membership (iGate).
- Participate as a team member in multi-functional matrix based NPD project teams where appointed.
- Demonstrate effective project management skills through the delivery of project deliverables in accordance with project timelines.
Technical transfer of products to EMOs.
- Write product summary for site variation and get approval from all product shareholders.
- Review and approve documents related to technical transfer and validation activities.
- Maintain project management timelines and deliver fit for purpose products.
- Provide Technical Support to the EMO’s; troubleshoot any technical problems encountered by EMO.
Ensure all relevant local Technical SOPs are reviewed regularly and up to date and consistent with current standards.
- All SOPs current and reviewed regularly.
About You
To be successful in this role, you will possess the following experience, qualifications and competencies:
- Minimum requirement is a post -graduate qualification (MSc or equivalent) in chemistry, pharmacy or a related discipline.
- Minimum 10 years in the pharmaceutical or cosmetic industries.
- Good understanding of GMP and Quality Management System (QMS).
- Demonstrated ability and understanding of project-based work.
- Regulatory affairs knowledge and successful interactions with regulatory agencies would be advantageous.
- Strong planning and organisational skill.
- The incumbent must be an exceptional problem solver, with structured and logical approach to work.
- A blend of quality / technical knowledge and experience and the ability to articulate these needs and their solutions, at all levels of the organisation.
- Strong communication skills, both verbal and written, and the ability to use those skills to effectively communicate and collaborate with different levels and departments within the organisation.
- The ability to assess risks and shape decisions.
- Negotiation skills to ensure satisfactory outcomes within and outside the organisation.
- Able to multi-task and make things happen with a sense of urgency.
- A positive outlook and a desire for results are essential qualities.
Personal attributes desired includes:
- High level of attention to detail.
- Ability to sustain a high workload.
- Team player.
- Logical and clear thinking.
- Decisive with a keen sense of urgency.
