Job Details

Company: CTC Resourcing Solutions
Location:
Reference: 895604-P
Closing Date: 19 May 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

•Manage portfolio of projects, support a discipline and/or provide a service. If applicable, may provide functional expertise in area of responsibility. •Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance. With training and specific delegation may also approve relevant deliverables.

Requirements:

Reference Number:         895604-P

Type of placement:         Contract – 16 Months

Location:                        Basel, Switzerland

Purpose

Manage projects and/or processes and allocated resources to support departmental
projects and objectives according to agreed timelines and standards and assure
compliance with GMP is maintained in TRD.

Main Responsibilities:

• Manage portfolio of projects, support a discipline and/or provide a service. If applicable, may provide functional expertise in area of responsibility.
• Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance. With training and specific delegation may also approve relevant deliverables.
• Support project related activities (e.g. interpret results, evaluate data, draw relevant conclusions).
• Perform inspections and audits as required
• Contribute to the evaluation of new QA tools.
• Write GMP relevant documents in own area of responsibility (e.g, SOPs with
• global applicability).
• Supervise 0-3 direct/indirect reports or a team.
• Provide support to TRD line functions in GMP compliance related issues (e.g.
• training, document management) .
• Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance’s, SOPs, HSE, etc). Promote and enforce compliance to guidelines. If managing associates, ensure same for them.
• Support project management functions as a sub-team member or in preparation for a PAI.
• Lead and support direct reports in line with values and behaviour
• including objectives setting, performance evaluations, development planning
• and participate in recruiting process.

Qualifications and Experience:

• Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent
• Basic degree in scientific or relevant discipline (BS or equivalent)
• Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
• Good knowledge in English (oral and written) required; fluent in site-language desirable
• At least 2 years of relevant experience.
• Ability to negotiate and communicate .
• Sound scientific, technical and regulatory knowledge in a specific area.
• VerygoodknowledgeofcGMPs,workingknowledge
• of safety and environmental regulations and guidelines.
• Good knowledge of drug development .
• Good organizational skills.
• Good ability to analyze and evaluate GMP compliance

Address:	Head Office Münchensteinerstrasse 41 4052 Basel Switzerland	Reasons to work for CTC
Tel:	+41 61 695 88 66
Fax:	+41 61 695 88 67
Website:	Visit Our Web Site