Quality Control (QC) GMP Manager – Nanoform Finland Oyj
13.3.2022About Nanoform
Nanoform is an innovative drug particle engineering and nanotechnology company that provides novel API particle-size reduction services, helping to de-risk drug development projects in the pharmaceutical pipeline. We work together with international pharma companies to significantly increase the number of drugs that reach the market through our best-in-class nanoforming™ services.
Quality Control (QC) GMP Manager
With the view of developing our organization further, we are now seeking Quality Control GMP Manager to support our quality control team. The job is located at our facilities in Helsinki, Finland.
You will be responsible for
- Developing procedures and writing working instructions, SOPs, and qualification documents
- Managing laboratory operations including people and equipment maintenance
- Reviewing chromatographic, chemical, solid state, and microbiological data and related laboratory records such as notebooks, paper base or electronic, according to Standard Operating Procedures (SOPs)
- Reviewing equipment qualification and calibration records according to SOPs
- Ensuring compliance of generated data with analytical procedures, Pharmacopeia(s), Customer criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
- Performing non-routine and complex analytical data review ensuring scientific soundness and method validation
- Reporting deviations and OOS/OOT results and participating in related investigations
- Participating in the Release process of raw materials, Drug Substance and Drug Product.
- Training laboratory personnel
- Conducting and participating in internal Audits to evaluate QC performance and compliance.
Ideal experience
- You have a degree in pharmacy, chemistry, microbiology, biotechnology or in an equivalent field
- Working knowledge of SOPs, Pharmacopeias and GXP Regulations
- Solid verbal and written English communication skills
- Excellent attention to detail
- Strong technical knowledge and understanding of laboratory procedures, methodology and standards
- Capacity to independently review laboratory reports and analytical data
- Capacity to provide clear and concise feedback and/or documentation of results
- Experience in using electronic Quality systems (LIMS, QMS, CDS, CAPA, others)
- You are used to work with MS Office programs.
Personal qualities we are looking for
- You are a doer and have an accurate working style
- You are flexible in working in a team as well as independently
- You have an ability to work in a high-performance environment
- Excellent English both written and spoken.
What we offer to you
- A great team to join with skilled and highly motivated colleagues
- Encouraging and forward-looking team spirit
- You will be part of a team that invents world-class solutions for the pharmaceutical industry
- We provide extensive learning opportunities. You are able to utilize your skills and competencies widely as we continuously create something new
- We like challenges and want everyone to enjoy solving them together.
You will get to be part of a unique start-up in the pharma industry.
Interested?
To apply for this position, please supply a covering letter and CV by 31.3.2022.
Please note that we may already start the interviewing process during application period.