QA / QC Expert / no-633

Status: 
active
Location: 
4070 Basel (Klybeck)
Start Date: 
2019-01-07
End Date: 
2019-12-15
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
1.960
Assignment: 

Background

For our customer located in Basel/Switzerland we are currently looking for (m/f) an QA / QC Expert

  • Type of placement:  12  months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area
  • Salary:  level 2, please ask us for the exact rate range 

(monthly all in salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k)

 

ROLE PURPOSE

Provide QA oversight on all external suppliers for BDSS. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management at BDSS.

 

MAJOR ACCOUNTABILITIES

  • Responsible for initiating and driving supplier qualifications
  • Upgrade of supplier qualifications from clinical to commercial in scope of the BDSS going commercial project
  • Upgrade of raw materials and consumables from clinical to commercial in scope of the BDSS going commercial project
  • Oversight on all suppliers and raw materials used at BDSS
  • Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
  • Manage and evaluate change notifications from external suppliers
  • Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
  • Perform local implementation of Quality Manual and global procedures (gap assessment, local changes in SOPs...)
  • Manage projects, and provide QA support. May provide functional expertise in area of responsibility (supplier qualification).
  • Represent BTDM BDSS Quality in initiatives. Liaise with key stakeholders across NTO to identify compliance standardization needs.
  • Lead project related activities (e.g. development of new tools and processes).
  • Provide support to BTDM BDSS line functions in GMP compliance related issues in area of expertise.
  • Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
  • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines.

 

KEY PERFORMANCE INDICATORS / MEASURES OF SUCCESS

  • Supplier oversight and supplier approval rate
  • In accordance with BDSS objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections.
  • Act in accordance with our customer  standards, in particular ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
  • Maintain sound working relationships with partners and customers.
  • Feedback from other team members
  • Meet quality and timelines in all projects
Requirements: 

EDUCATION / EXPERIENCE

  • Education: 

o Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
o Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)

  • Languages: 

o Fluent in English (oral and written) required; fluent in site-language desirable

  • Experience/Professional requirement: 

o At least 3 years of relevant experience.
o Strong ability to negotiate and communicate.
o Good team working skills
o Sound scientific, technical and regulatory knowledge.
o Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
o Good knowledge of drug development and drug substance production.
o Good organizational skills.
o Good and proven ability to analyze and evaluate GMP compliance.

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JobPosting Application

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