- As DQA officer you are responsible to assure the quality of the information that will be filed during the application of a newly developed (generic) drug product.
- You will assure the quality proactively by setting up systems that will help the project teams to build quality into the products and you will check their work regularly to verify the information supplied for the filing is indeed of the desired quality.
- Next to this you are the GMP expert in the project teams that team members can go to in case of questions related to GMP guidelines.
- Perform data integrity audits of scientific reports that can end up in filing documentation
- Review data that will be discussed during phase gate meetings and host the phase gate meeting
- Be the GMP guideline specialist in the project teams that can guide the team members to relevant guideline sections (eg FDA, USP, EU-GMP. Ph. Eur. WHO, PICS, ICH)
- Perform regularly internal audits (project teams, supply chain, facilities)
- Perform vendor qualification audits
- Train project team members on GMP guidelines / internal procedures
- Set-up and maintain electronic QMS
- You are part of a team of 3 DQA officers each responsible for 2 clusters which run several projects at the same time.
- The QA team further consists of an Officer QA systems and a validation specialist.
- The team is headed by the DQA manager who reports into the head of DQA at the R&D organization in Hyderabad India.
- Locally the head of DQA has managerial reporting line into the director Continuous Improvement (Lean Six Sigma) & DQA who is part of the management team of the site.
Technical leads, Scientists in project teams, Employees in supporting departments (supply chain and facilities), DQA colleagues of other DRL R&D sites (mainly IPDO Hyderabad India).
Scientific (MSC equivalent or PhD), preferably Pharmacy, Chemistry or Life sciences
Since we are an international working environment the routine communication is English: Speaking and writing must both be excellent.