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OPKO Biologics, a dynamic Bio-Tech company that conducts global clinical studies in advanced stages, is looking for QA CMC and Preclinical

Job Description

Ensuring quality test results of analytical and bioanalytical test methods
Conducting Internal Audits in the GLP laboratory and CMC departments
Supplier qualification including Supplier’s audit
Writing and updating standard operating procedures
Approve controlled documents as protocol, reports and CoA
Review Calibration records, equipment files
Support Validation of Laboratory test methods, equipment and computerized system
Provide training to CMC and Preclinical team members
Deviation ,CAPA and change control management

The company is located in Kiryat-Gat.

Requirements

At least 3 year of experience in pharmaceutical, medical device company – significant advantage
requirements; i.e., Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and OECD guidelines, Good Documentation Practice (GDP)– required
BSc/BA in science- required
MSc/MA in science- advantage
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Ability to prioritize, self-control and diligence in completing big demanding projects
Strong written and verbal communication skills including good command of English language
Effective time management and organizational skills
Permanent attention to details, accuracy in work
Ability to establish and maintain effective working relationships with coworkers, managers and vendors

OPKO Biologics, a dynamic Bio-Tech company that conducts global clinical studies in advanced stages, is looking for Records Management Specialist.

Job Description

Review of Clinical trial files for accuracy, completeness and ensure TMF inspection ready
Preparation, handling, distribution, filing, and archiving of clinical trials documentation according to the scope of work and standard operating procedures

· Provide training and support to systems users (such as CTMS, eTMF)

The company is located in Kiryat-Gat

Requirements

1 year of experience in similar position in well-established CRO, pharmaceutical, medical device company or 1 year of experience as a Study coordinator – significant advantage
Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, TMF RM – required

· Knowledge of regulatory requirements in the EU, APAC, East-Europe and south-America regions- significant advantage

BSc/BA diploma or equivalent

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Ability to prioritize, self-control and diligence in completing big demanding projects
Strong written and verbal communication skills including good command of English language
Effective time management and organizational skills
Permanent attention to details, accuracy in work
Ability to establish and maintain effective working relationships with coworkers, managers and vendors

PQE Group is a Contract Quality Organization and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group, we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turnkey quality solutions and focuses on offering exceptional cost-effectiveness, whilst maintaining the highest quality standards for our Clients.
Due to our constant growth, we are looking for a new Validation Senior Consultant to join our team in Israel.
Responsibilities include, but are not limited to, the following:
Collaboration in project teams
Various roles in the validation process including the creation and execution of qualification protocols (IQ, OQ, PQ),
Development of validation plans
Performance of risk assessments.
In addition, this role requires close interaction with clients and the ability to work and communicate with both team members and external stakeholders.

Requirements:
Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
2-4 years of experience in the Pharmaceutical Industry enviroment
GxP knowledge
Knowledge of Computer System Validation
Availability to travel (at least 50% of the working time)
English Fluent ( at least B2/C1)
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.