About iNova
iNova is a different kind of health company. We lead the way to better health by delivering innovative, patient-centric products that improve lives 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.
The Opportunity
We have an opportunity for a Quality Manager to join our Quality Assurance team on a full-time basis.
As the Responsible Person according to article 17 and 18 of Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1), core focus of the role is to ensure the facility handles medicinal products appropriately.
* Direct technical supervision of the facility.
* Ensures import and wholesale trading in medicinal products conform to GDP rules described in Annex 4 of MPLO.
* AUTHORIZED TO ISSUE INSTRUCTIONS WITHIN ITS SPHERE OF ACTIVITY.
* Jointly with the company management ensures deputization by adequately qualified specialists.
* In case facilities cease operations or can be expected to cease imminently, the Responsible Person must report this situation to Swissmedic without delay.
Market Release
* Decides on the market release of a batch before it is placed on the market.
* Checks whether:
o a valid batch certificate issued by the manufacturer is available;
o the batch was manufactured in conformity with GMP rules described in Annex 1 of MPLO;
o the batch in question fulfils the requirements of the authorisation;
o the conditions described in Articles 11 and 12 of MPLO have been fulfilled;
o the entire supply chain is in conformity with the authorisation and GDP rules described in Annex 4 of MPLO.
* Complies with Swissmedic regulations.
Key Accountabilities And Performance Indicators Include
* Implements and maintains a quality management system.
* Focused on the management of authorised activities and the accuracy and quality of records.
* Ensures initial and continuous training programmes are implemented and maintained.
* Coodinates and promptly performs any recall operations for medicinal products.
* Ensures relevant customer complaints are dealt with effectively.
* Ensures suppliers and customers are approved.
* Approves any subcontracted activities which may impact on GDP.
* Ensures self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
* Keeps appropriate records of any delegated duties.
* Decides on the final disposition of returned, rejected, recalled or falsified products.
* Approves any returns to saleable stock.
* Ensures additional requirements imposed on certain products by national law are adhered to.
* Notifies Swissmedic according to MPLO Article 41 in case of any amendments to the content of the license or all major changes to facilities, equipment or procedures used for import or wholesale trading with medicinal products and which could influence quality.
* Reviews and evaluates Product Quality Reviews of products, for which iNova Pharmaceuticals (Switzerland) AG is Marketing Authorisation Holder.
* Ensure goals and priorities support the business strategic directions.
* Responsible for Quality management Review (QMR) within a region and support global QMR.
* Drive consistency and standardization across distribution teams.
* Responsible to identify, communicate and mitigate quality and compliance performance risk.
* Support audit activities if required.
About You
To be successful in this role, you will possess a tertiary education (university or equivalent / higher technical institute) in the area of natural sciences. Additional requirements include:
* Technical know-how of the processes a Responsible Person will be responsible for.
* The Responsible Person should speak the Swiss national language spoken in the company and English.
* The Responsible Person must live within reasonable distance of the site.
* At least 5 years' experience in quality in pharmaceutical industry.
* Proven track record of knowledge and experience of GMP as well as GDP.
* Able to handle multiple tasks in a fast-paced environment.
* Takes initiative and ownership.
* A problem solver.
* A blend of technical knowledge and experience and the ability to articulate these needs and their solutions.
* Be able to work independently and in a team environment across multiple functions and countries.
* Very good communication skills both written and oral.
Additional Requirements / Working Conditions
* Adhere to company values at all times.