Dechra is an international specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide.
The Dechra group employ over one thousand people worldwide. Our six Dechra Values: Dedication, Enjoyment, Courage, Honesty, Relationships and Ambition reflect the best aspects of behaviour and competence in Dechra. We embrace the values at every level of the business and everything about the business is underpinned by our values. How we talk to the people that matter, the way we always look to do things better and how we think of the people and the animals beyond the product.
We are active in Companion Animal, Equine and Food Producing Animal products and support our clients in practice with a wide range of materials and technical advice.
Genera is a company with more than a hundred years of tradition in manufacturing animal health products, food supplements in the form of vitamins and minerals, disinfectants use and plant protection products. Since 2015 it is a part of the Dechra Group.
For our Technical Services team at Zagreb site we are looking for a:
Technical Services Associate / Senior Associate (m/f)
- To provide the technical support for executing new product commercialization projects from Dechra PD (Product Development) pipeline using product lifecycle approach
- To provide the technical support for executing optimization projects for currently approved products from site or from other internal sites or from CMOs (Contract Manufacturing Organizations) using product lifecycle approach
- To provide the technical support for troubleshooting currently commercialized problem products; new production equipment selection and evaluation and rework evaluation of rejected batches
Support the TS Site Lead and represent the department on project team level for the following key tasks:
- Execution of product commercialization projects for the site (NPI and post approval changes). This will require close collaboration with PD, Production and QA groups on NPIs using product lifecycle approach, preparation and approval of GMP documentations to support such projects, scheduling, raw material acquisition, supervising TS batch manufacture, etc.
- Identifying potential process improvements for existing commercial products including proposals to fro formulation / process optimization. Then support implementation of changes after management approval
- Provide technical support to Production to solve problems as they occur on the shop floor. This responsibility includes both troubleshooting of active products and potential rework procedures for failed batches
- Assist in new equipment evaluation by interfacing with the Engineering group
- Assist in activities for successful transfer of new equipment to production, including training of both supervisors and operators
- Project lead for evaluating and qualifying alternate sources of raw materials
- Using the Product lifecycle approach and statistics, take project leadership for the technical activities involve in the commercialization of internal products during Product Development, Registration, Optimization, Validation / Launch of veterinary drug products as applicable
- Assist in the Technical assessment of products / projects (development and commercialized products for optimization/site transfer)
- Assist in implementing the product life cycle program for the site to ensure compliance with Dechra’s commercialization standards and compliance with current Global Regulatory expectations
- Proactively identify and troubleshoot formulation and process type issues of products manufactured internally to improve product quality and to minimize product supply interruptions
- University degree in life sciences, engineering, pharmaceutics, chemistry, or similar fields
- Minimum of 5 years of industrial experience in the pharmaceutical or related industry, or an equivalent combination of education and experience with knowledge of pertinent Regulatory and Industry guidance’s and regulations
- The ability to design, develop and implement effective tech transfer and product lifecycle strategies for the dosage forms manufactured by the site and a solid working knowledge of manufacturing platforms and pharmaceutical facility infrastructure
- An understanding of the dosage form development process, along with some knowledge of process development techniques, cGMP regulations, FDA and EMA regulations, and recent trends in product lifecycle concepts
- A “hands-on” knowledge of pharmaceutical manufacturing equipment
- Fluency in written and oral English
- Proficient computer skills
- Effectively determine targets, priorities, the time required, the actions required and the resources needed to achieve certain goals
- Problem analysis and decision making skills
- Team worker
To apply, please send your CV and Cover letter only in English via application link.