QA Compliance Manager

Harvey Nash is looking for a QA Compliance Manager for a 6 + month project in Switzerland.

The role is for a candidate to manage projects and processes to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP is maintained. Minimum focus of the position will be on the investigation of technical complaints.

You are responsible for

. Managing portfolio of projects (third parties, analytical instruments and manufac-turing equipment as per area of responsibility); supporting a discipline and/or providing a service on his/her own or with a team of associates.
. Reviewing and approving deliverables (eg procedures, records, third party work, contractors, clinical trial material, components, gap assessments) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance.
. Leading project related activities (eg development of new tools, processes, Quality Initiatives, QM/QDs implementation, Quality Plans, SQRA, training activities, qualification and facility upgrade activities, IT validation projects).
. Writing, reviewing and approving documents (eg procedures, records, SOPs) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance
. Performing inspections and audits as required
. Contributing to the evaluation of new QA tools.
. Providing support to line functions in GMP compliance related issues in area of expertise (eg medical device standards).
. Supporting a culture of high performance and trust; assuring that the required level of knowledge and skills is available and identify competency gaps; establishing and implementing training and development plans.
. Meeting internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc).
. Promoting and enforcing compliance to guidelines. If managing associates, ensuring same for them.
. Supporting project management functions as a sub-team member or in preparation for a PAI.
. Writing/contributing to internal compliance policy and/or comment to regulations.
. Guiding team members in line with clients values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.
. Approving GMP relevant documents and decision making according to current SOP (Global TRD QA and TRD Quality Responsibilities; Approval and Release Authorities)
. Managing Deviations, Investigations, CAPAs and contributing to or writing trending reports for Deviations/Technical Complaints/Change requests for products and processes of TRD GMP line units and recommending necessary actions to supervisor (Quality Matrix).
. Contributing to or writing First Time Right performance reports
. Supporting internal audits of the client and audits of third party packaging and la-beling as required
. Fulfilling SME role as defined in the QA DSM SME Matrix.

Requirements

. Minimum: Basic degree in science or relevant discipline (BSc or equivalent)
. Desirable: Advanced degree in science of relevant discipline (MSc or equivalent)
. Fluent English required (oralGood skills in site (local) language (German) desired (oral).
. Good knowledge of cGMP, working knowledge in technical development, production or QA
. Sound scientific, technical and regulatory knowledge
. Broad working experience (min. 5 years) in TRD, production or QA (eg several years of experience as head of laboratory).
. Good organizational skills
. Good and proven ability to analyze and evaluate GMP compliance.

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call. I am looking forward to receiving your application.