QA Compliance Expert / no-691

Location
CH-Basel
Start
02/05/2022
End
30/04/2023
Workload
100 %
All-in / Hour
58chf/h gross
Total Hours
2.080

Deadline:

 

QA Compliance Expert / no-691

Location
CH-Basel
Workload
100 %

Start

02/05/2022

End

30/04/2023

DEADLINE

  • CH-Basel
  • CH-Bael02/05/202230/04/2023100 % 2.08058chf/h gross

For our customer located in Base Klybeck/Switzerland we are currently looking for  a: Compliance Expert (m/f/d)

  • Location: Basel Klybeck
  • Branch: Pharma
  • Duration: 1 year

Tasks & Responsibilities

Operational:
• Ensure all activities in compliance with cGxP, incl. data integrity
• Planning and supporting PQR/APQR activities
• Support site qualification and validation activities (planning, advising, review)
• Implementation of Quality Systems
• Supplier management activities (agreements, oversight, audit), if applicable
• Preparation/support and coordination of CAPA/follow-up
• Audit and inspection preparation and support
• Change control review/approval for complex changes
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.)
• Ensure process quality assurance according to regulations
• QP declaration review and approval
• Ensure applications, certificate maintenance to local HA
• SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country
• As applicable, act as Site reg-CMC Facilitator
• As applicable, act as site Change Coordinator
• As applicable, act as Site DI responsible

 

HSE:
• Comply with all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments
• Preparation and participation to internal HSE audits
• Responsible for participating in initial training and retraining

Must Haves

• Experience in pharmaceutical quality control, quality assurance or production

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

• Good (oral and written) in English; fluent in local language (oral and written)

• Collaboration; result-oriented
• Operational Excellence; Continuous Learning; Digital & Tech Savvy; Being Resilient
• MS Office applications and other standard IT applications supporting Quality activities
• Quality Assurance; Knowledge of GMP; Quality Standards
• Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Technological competence; action oriented; functional professional skills; optimize work processes

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

  • CH-Basel
  • CH-Bael02/05/202230/04/2023100 % 2.08058chf/h gross

For our customer located in Base Klybeck/Switzerland we are currently looking for  a: Compliance Expert (m/f/d)

  • Location: Basel Klybeck
  • Branch: Pharma
  • Duration: 1 year

Tasks & Responsibilities

Operational:
• Ensure all activities in compliance with cGxP, incl. data integrity
• Planning and supporting PQR/APQR activities
• Support site qualification and validation activities (planning, advising, review)
• Implementation of Quality Systems
• Supplier management activities (agreements, oversight, audit), if applicable
• Preparation/support and coordination of CAPA/follow-up
• Audit and inspection preparation and support
• Change control review/approval for complex changes
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.)
• Ensure process quality assurance according to regulations
• QP declaration review and approval
• Ensure applications, certificate maintenance to local HA
• SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country
• As applicable, act as Site reg-CMC Facilitator
• As applicable, act as site Change Coordinator
• As applicable, act as Site DI responsible

 

HSE:
• Comply with all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments
• Preparation and participation to internal HSE audits
• Responsible for participating in initial training and retraining

Must Haves

• Experience in pharmaceutical quality control, quality assurance or production

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

• Good (oral and written) in English; fluent in local language (oral and written)

• Collaboration; result-oriented
• Operational Excellence; Continuous Learning; Digital & Tech Savvy; Being Resilient
• MS Office applications and other standard IT applications supporting Quality activities
• Quality Assurance; Knowledge of GMP; Quality Standards
• Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Technological competence; action oriented; functional professional skills; optimize work processes

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

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