We are looking for a Commercial Quality Specialist for one of our clients in Petah Tikva (Israel).
Length of the project: initially for 6 months
Reporting to the Responsible Person, Global Supply Chain & OEU commercial quality
Commercial Quality Specialist
To provide QA support for local office and support distributor QP function. Ensure activities are carried out as per GDP & ISO guidelines. Carry out activities such as auditing, deviation, review, change control, update and review of SOPs and training. Carry out project management activities with regards new business, new products, new processes and to drive continuous improvement within the business locally.
Your Job1) 60% of the time - Maintenance of the company’s Israel Quality Management System & ISO certification
Responsible for the maintenance of the APIL Quality system as part of the local / regional and international systems linking into Corporate Quality system, compliant with relevant GxP’s, ISO 13485 and relevant local legislation:
- Support all local Quality requirements and ISO certification
- Ensure alignment between local quality SOP’s, regional SOP’s and Corporate Standards, Policies and Procedures through review and update as required.
- Responsible for the Document controller functions on CORAL and to provide cover for the archiving administrative function.
- Support the Change Control & Risk Assessment system within Israel.
- Conduct internal audits & self-inspection of local QMS to evaluate compliance, providing a non-conformance report to Management Team and Dir. / RP APIL.
- Maintain CAPA / Deviation program and initiate Corrective Action plans with department managers as appropriate.
- Conduct GMP and GDP training for all local personnel and maintenance of training records for internal staff.
- Support audits conducted by Corporate Audit including management response to audit findings.
- Provide monthly KPI reports to management including audit results and status of Corrective Actions.
- Support the International local commercial Management with contract QP in recall situations.
2) 20% of the time - Compliance Management of Third Party Quality Systems
As part of Global Supply Chain Quality:
- Ensure all external contractors meet the requirements of the company Quality Standard, Policies and Procedures.
- Perform audits on all Supply Chain vendors to validate compliance with Quality System and Service Level Agreements.
- Support GxP compliance of TPM’s, 3PL’s, Distributors/Partners
- Where required conduct vendor qualification audits for any proposed change in the company distribution centre and Bona Fides.
- In conjunction with Packaging Design & Development support the develop test protocols for cold chain packaging and shipping system qualification; support real-time testing and report requirements.
- To assist in all new product launches
- Quality facilitator for the local teams supporting quality improvement initiatives
- Support quality improvements initiatives across the International region as part of OEU commercial quality management review.
- Support Manufacturing and external QP for local quality & release requirements.
- Implementation of the falsified medicines directive.
- Ensure obligations from the Good Distribution Practices incorporated into Quality management system.
- Monitor investigations due to temperature excursions and implementation of the temperature monitoring and shipping project.
Education & Experience
- The equivalent of 3 years college education in a medical/scientific related field. At least 3 years’ experience in quality related or production in the pharmaceutical or medical device industry.
- Previous administrative experience, working at a senior level, ideally in a pharmaceutical or medical device company.
- Previous experience with ISO standards and GMP quality systems required for pharmaceutical/ medical device industry.
- Excellent administrative skills, including good proficiency in Word, Excel and PowerPoint.
- Willingness to learn new additional software packages as necessary.
- Ability to work through procedures rather than instruction
- Ability to manage own workload without supervision.
- Ability to demonstrate flexibility in responding to urgent requests
- Ability to operate according to agreed performance standards such as timelines.
- Observe and comply with company standards and procedures.
- Enthusiasm and quality improvement orientation
We are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
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