Vakante Jobangebote finden Sie unter Projekte.
Global Quality Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Engineering, Support
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Bachelors degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering
- 4+ years of QA experience in a pharma or biotech industry
WHAT YOU'LL BE DOING:
- Maintains a high level of understanding of relevant production processes and quality systems
- PerformstheQA review and approval of thefollowingGMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
- Change Requests
- Batch Records and associated documentation
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols and Reports
- Standard Operating Procedures
- Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
- Collaborates with, and influences, other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Collaborates in data analysis and report creation on quality metrics and key performance indicators
- (USBC) Act as process execution lead/process owner for one or more of the following areas:
- Accountable for Supplier Management including but not limited to Annual Assessments, Quality Assurance Agreements, and KPI's.
- Accountable for Quality management of US Distribution Centers.
WHAT YOU NEED TO BRING TO THE TABLE:
- Excellent oral and written communication skills
- Strong ability and motivation to learn.
WHAT'S IN IT FOR YOU?
Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.
WHAT ARE YOU WAITING FOR? APPLY NOW!
Recruiter: Stephanie Tulloch
Yoh, a DayJ2W: SCIENTIFIC; MONJOB
TAX TERM: CON_W2 J2WNECLIN
Ref: AZNJP
SFSF: LS
Projektdetails
-
Einsatzort:
Newark, Vereinigte Staaten
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges