GMP Support / Compliance Manager / no-096

Status: 
closed
Location: 
4070 Basel
Start Date: 
2019-05-20
End Date: 
2019-12-31
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
1.296
Assignment: 

Background

For our customer located in Basel/Switzerland we are currently looking for (m/f/d) an GMP Support / Compliance Manager:

  • Type of placement: 7 months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area
  • Salary:  level 3, please ask us for the exact rate range 

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

 

Purpose of the role: Cleaning Validation and Compliance Specialist 

Establishes and maintains the GMP management system of the Local Supply Centre, serves as the point of contact between QA and the UNIT for general inquiries, and represents the UNIT in GMP related initiatives as appropriate. 

 

Major Activities: 

GMP Officer: 

  1. Management of cleaning verification activities as well as support and representation of the GMP officer 
  2. Preparation of the relevant documentation (assessments, protocols and reports) for cleaning verifications related to the production of solid dosage forms in multipurpose facilities and equipment 
  3. Supporting cleaning verification activities on shop floor. 
  4. Regular updating of the cleaning validation master documents. 
  5. Representation and support of the GMP officer in ensuring overall GMP compliance including the handling of deviations and change controls 
  6. Preparation and support of internal audits and HA inspections 
  7. Authorship and review of production and project related GMP documents (Qualification documents, trending reports, SOPs, Logbooks) 
  8. Supporting and giving GMP training in collaboration with other team functions to ensure training compliance 

 

Requirements: 

Experience: 

  • Track record of working in GMP environment and having quality- or production-related responsibilities 
  • Preferably experience in the field of cleaning validation in drug product or drug substance manufacturing 
  • Microbiological Knowledge is a plus 
  • Strong interpersonal and communication skills; needs to be a good team player 
  • Formal training in continuous improvement methodology such as LEAN/6-Sigma; Green or Black Belt certification is desirable 
  • Good project management skills, being focused on results 

Qualification:

Pharmacist, Chemist, Pharmaceutical Engineer or other equivalent natural science education 

Languages:

German and English in spoken and written (mandatory) 

Remark:

Students who recently graduated and already have industrial experience through internships, that could be available IMMEDIATELY, would also be considered for this role. 
 

 

 

Kindly be informed that our customer is located in Switzerland. Therefore only applications within the EU or candidates holding Swiss work permission are required. 
The SymplyVision-Team is looking forward to receiving your application (Word file is highly appreciated)