Senior Associate QA (GMP)
Orion Group · Netherlands, Provincie Noord-Brabant, Breda ·
- Work mode
- Hybrid
- Seniority
- Senior
- Employment
- Contract
- Category
- QA
- Experience
- 3+ years
Orion Group Life Sciences are looking for a Senior Associate QA (GMP) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 6-month contract. This is a hybrid role, where you have to be on site at least 2 days a week (Thursday fixed day). During initial onboarding and training 3-4 days onsite.
Main Responsibilities of the role
If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, [email protected] or contact Tim on 0044 7593448607
#opportunity #multinational #pharmaceutical #biotechnology #QA #QualityAssurance #GMP #product #quality #masterdata #BOM #SAP #criticalvalueverification #artworkapproval #SOPs #workinstructions
People are our business worldwide
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.
Main Responsibilities of the role
- To perform QA review and Approval for SAP Master Data and artwork.
- To ensure QA systems are maintained, improved and performance is appropriately monitored.
- To establish effective working relationships with the Global Artwork Center, Master Data, SCPM, Site SME’s and RA department, as well as QA Management.
- Perform review and approval of Master Data related activities (such as critical value verification and Bill of Materials).
- Perform approval of artwork for medicinal products.
- Act as author for operational SOP’s and Work Instructions.
- QA Review of operational SOP’s and Work Instructions.
- Participate in QA related projects as needed.
- Assist in various investigations as needed.
- Bachelor of Science Degree with relevant working experience or this position is also a good entry-level position for Master degree in Lifesciences.
- Preferred, but not required: previous experience in GMP/Pharma.
- MBO degree in Life Sciences or related field or the equivalent combination of education and/or experience.
- Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry for someone with a Bachelor or MBO degree.
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
- Accurate mindset
- Fluent in English language.
- Problem Solving Skills:
- Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
- Ensures compliance within regulatory environment.
- Develops solutions to technical problems of moderate complexity.
- Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues.
- Interprets generally defined practices and methods.
- Autonomy Skill:
- Works under general direction
- Work is guided by objectives of the department or assignment
- Refers to technical standards, principles, theories and precedents as needed.
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes and escalates problems.
- Contribution:
- Contributes to work group/team by ensuring the quality of the tasks/services provided by self.
- Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.
- Provides training/guidance to others and acts as a technical/scientific resource within work group/team.
- Establishes working relationships with others outside area of expertise.
- Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, [email protected] or contact Tim on 0044 7593448607
#opportunity #multinational #pharmaceutical #biotechnology #QA #QualityAssurance #GMP #product #quality #masterdata #BOM #SAP #criticalvalueverification #artworkapproval #SOPs #workinstructions
People are our business worldwide
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.