Senior QA Specialist, Syntese / 1688
Syntese A/S, owned by the Ferring Group, manufactures Mesalazine (5-aminosalicylic acid/5-ASA), an Active Pharmaceutical Ingredient (API) used in human treating Inflammatory Bowel Diseases. The production plants are placed in Denmark outside Copenhagen and in India. The Mesalazine quality product is distributed to customers all over the world. Syntese is now working on the approval to build a new state of the art production site in Denmark.
Having nearly 30 years´ experience, Syntese is the most experienced supplier of Mesalazine in the world. Syntese is GMP certified and FDA approved for delivery to the US. They are also owner of a worldwide marketing certification.
Syntese is dedicated to continuously innovate and improve their product and the process in order to be able to supply global customers with the best quality product possible at a competitive price and with right on time deliveries. Syntese is an environmentally conscious company – proven by an ISO 14001 certification, an ambitious energy reduction project, annual environmental reports and a Copenhagen County Environmental Award.
The company has a yearly turnover of about 300 million DKK. and employs 100 engaged employees. As Syntese is a growing organization, we are now looking for a Senior QA Specialist to strengthen the Quality Team. You can read more about Syntese at www.syntese.dk
In the Quality Unit they are 25 employees, 10 in QA and 15 in QC. The Quality Assurance function is responsible for all global quality systems and QA related regulations in the company. QA is also responsible for release of the API. The work is carried out with the mindset of the Ferring Group leadership principles: Purpose, Performance, Empowerment, Innovation, Accountability, Collaboration and Transparency.
Senior QA Specialist
- Operational tasks and responsibility for different quality matters
- High influence on the working processes
- Enhance the competences within the team
- Balanced in strategic thinking and operational focused
- Role model in stakeholder management across functions
- A positive change agent
You deliver best in class solutions and are driven by high standards and ambitious goals within the field of QA, where you bring the right mindset to the group. You work according to the highest standards of current practice in order to fulfill the company’s needs within the QA area. You will play an important role in the on-going development of the mindset within Syntese. As part of the QA team, you also participate in cross-functional projects.
Your essential task includes:
- Lead cross-functional quality projects
- Contribute in training and support knowledge sharing within Syntese
- Responsible for own tasks regarding the quality system
- Participate in cross-functional teams, providing guidance and risk-based options
- QA Support to quality system projects also within IT and electronical systems
- QA support to qualification and validation activities
- Participate in external and internal audits
- Release of API
- Prepare and approve various types of documentation within the responsibility of QA
You will be part of a great team with skilled and dedicated colleagues working in a positive environment characterized by helpfulness and room for having fun at work. Syntese is a growing organization offering you opportunities for personal development. You will be encouraged to bring forth new ideas, discuss concerns and share feed-back with colleagues and management. It is this freedom and respect shown to all employees, that makes Syntese an attractive place to work.
The preferred candidate has a master within chemistry, pharmacy or similar. You have a minimum of 8 years solid experience in Quality Assurance from the GMP regulated pharma industry. Knowledge within API and finished products will be a plus.
The preferred candidate will have the following profile:
- You are likely to be MSc, Chemist, Biologist, MSc in Pharmacy or similar with a strong scientific knowledge
- You have +8 years of solid QA experience from the GMP regulated industry
- Strong quality mindset and profound knowledge of the GMP regulations
- Experience with equipment qualification and process validation
- Experienced as QA within software validation, electronic system implementation and other IT related projects
- Assess quality with a risk based, holistic and scientific sound approach
- Ability to motivate and maintain committed colleagues, sharing the goals and vision of Syntese
- Proactive, ambitious and solution-oriented personality
- Flexible and development oriented - See it as a challenge to be part of a development process
- By your positive mindset and attitude, you put your marks on the role by influencing the environment and colleagues
- Fluency in English with good verbal and written language skills is a given
The successful candidate is bright, ambitious with an easy, yet assertive personality. You have a “can-do” attitude, are flexible and have a high level of work capacity as well as a “out of the box” thinking personality. You have strong analytical and problem-solving skills. You must be a highly motivated, self-driven and dependable individual with a good sense of humor. You are passionate and ambitious about quality and at the same time motivated by playing an important role in the development of mindset and procedures in an international environment.
Syntese offers an attractive salary package and other employee benefits as well as a very good working atmosphere. You refer to the Head of Quality Unit, Syntese.
Best Talent is responsible for the recruitment for this position at Syntese and reviews your application on a confidential basis. Forward your application including your CV attention ”1688/Senior QA Specialist ” by way of e-mail to email@example.com You can read more about Best Talent at www.besttalent.dk.