מדעים/ביוטק

Qa Specialist

456128

תאריך עדכון

24/01/2022

תיאור המשרה

ROLE AND RESPONSIBILITIES

Procore’s competent Quality Assurance Manager is responsible for ensuring that the quality of medical devices

(MD’s)/pharmaceuticals being manufactured meet prescribed quality levels. The Quality Assurance Manager

will organize and direct all quality related issues of ongoing MD’s/pharmaceutical related research and

development, manufacturing and operation (logistics, export etc.) of raw materials and products in our

company. The QA Manager will also be responsible for working with the R&D, operation and manufacturing

team members, as well as developing QA SOP’s, processes and tools to enhance quality governance in the all

departments. The QA Manager must ensure staff have the training, guidance and discipline to effectively carry

out their day-to-day duties while keeping GMP and SOP’s at all times. The QA Manager must be able to analyze

data, embrace new QA methodologies and help develop solutions to challenges as they arise, and to contribute

new ideas within the company.

Specific duties of a pharmaceutical/MD Quality Assurance Manager include among others:

· Develop/implement & maintain QA systems & activities according to the company SOP’s and

regulatory bodies like the FDA, CE and Israeli MOH

· Write and implement SOP’s

· Ensure all QA records/SOP’s and other care-related documentation are up-to-date

· Analyzing the production process of pharmaceuticals/MD, finding out areas where errors prevail,

· Perform in-process inspections by minutely observing every activity of the MD’s/drugs being

manufactured or packed for visible defects

· Prepare, write and implement training to all employees

· Accepting or rejecting lots of MD’s/drugs on the basis of samples drawn

· Implementing quality assurance programs, giving inputs in preparing training manuals and quality

guidelines for production and quality control of MD’s/pharmaceuticals

· Develop protocols of acceptance with measurements and criteria’s of; raw materials, machines and

supplies that effects the product in the pre/in/after-process of finished product manufacturing

· Plan and execute; validation processes, calibrations and training programs for all needed aspects

according to the company SOP’s

· Maintain interactions with the company’s fellow colleagues, give them the needed services, and use

the proper consultants to achieve best performance and results

· Handling of CAPA etc.

· Work within approved budget

· The Quality Assurance Manager reports directly to the CEO/CSO

QUALIFICATIONS AND EDUCATION REQUIREMENTS

· Few years of relevant QA experience in pharmaceutical/biotech/laboratory industry (with

manufacturing activity)

· Experience in developing QA SOP’s/methodologies that complies with the FDA/EMEA/Israeli MoH

guidelines/regulations

· Solid understanding of manufacturing, performance evaluation and validation procedures

· Presentation and training capabilities

· Proficient in MS Office and specialized computer systems (e.g., priority or quality related software) · BSc/BA in science, biochemistry, microbiology, pharmacist or relevant field; MSc level will be appreciated PREFERRED SKILLS · Excellent communication, influencer and reliable · Exceptional organized, analytical, methodical and punctual · Aptitude in resolving issues and strive for success ADDITIONAL NOTES English at mother tongue level – preferred 

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