26 Jun 2014

Full-Time Various Vacancies

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Job Description

Smith & Nephew is a global medical technology business dedicated to helping improve people’s lives. With leadership in positions of Orthopedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma. Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Smith & Nephew has been supporting healthcare professionals for over 150 years.

For our Quality Control department in Curacao we are looking for a talented:

QUALITY SYSTEM SPECIALIST

Responsibilities:

• Performs Quality Oversights and report findings, assures follow up and corrections are done. Confirms corrective and preventive actions are implemented and effective;
• Performs Trending of Oversight Data and supports reporting of unfavorable trends to the CAPA Manager and plant management;
• Performs Batch Record review and provides release disposition of Ferms;
• Reviews Ferm dispositions in Deviation reports;
• Collects manufacturing and quality data for trending and Annual Product Review;
• Opens investigations and assign them to the responsible individuals of the finding and deviation area;
• Verifies that supportive documentation is attached to Deviation Records;
• Coordinates the interdepartmental activities associated with deviations/investigations;
• Reviews the deviation record and its associated child records and approve the completion parent. Assign; CAPA to the responsible Department including a description of the overall action required;
• Prepares deviations, CAPA trend. Creates reviews, approves and revises procedures;
• Responsible for preparing or assisting in the preparation of annual reports for the Smith&Nephew of Curacao;
• Actively supports the plant internal Audit Program by Operation.

Requirements:

• Bachelor or Master Degree in Microbiological, Biochemical, Quality Engineering, Engineering Sciences or Chemistry;
• Strong oral, report and writing skills in English.

Experience:

• A minimum of two years experienced in a Quality or Technical field in Pharmaceutical or Biotechnological Related Industry;
• Investigation or Technical Report writing skills in English.

SENIOR QUALITY CONTROL TECHNICIAN

Responsibilities:

• Performs microbiological procedures, including testing for in process samples, environmental monitoring, growth promotion testing, bioburden testing, bacterial identifications, water testing, chemical testing, moisture determination, preparation of media and agar, pouring plates;
• Execution of validation protocols;
• Reviews and revises Microbiology Standard Operating Procedures (SOP’s);
• Performs analytical testing for releasing of some components and all reagents;
• Performs equipment calibrations associated with analytical testing according to SOP’s;
• Ensures that the inventory of reagents and other necessary materials remains well stocked and ordered on time;
• Writes investigation reports;
• Makes schedules for QC laboratory activities;
• Trains Microbiology Technicians.

Requirements:

• Bachelor or Master Degree in Microbiological or Biochemical;
• Strong oral, report and writing skills in English.

Experience:

• A minimum of two (2) years of experience in a similar position in Pharmaceutical, Biotechnological or related industry or a combined 1 year experience with bachelor degree in microbiology or a curriculum with higher exposure in microbiology;
• Strong mathematical skills such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry;
• The incumbent should be able to work with Microsoft Office Professional Software package (including MS Word, MS Excel, MS Powerpoint and MS Access).

SENIOR VALIDATION SPECIALIST

Responsibilities:

• Generates qualification/ validation protocols and final reports, for test method validation and scientific studies for the Microbiology Laboratory;
• Guardian of the environmental control program of the plant;
• Assures high performance of the laboratory as has in change the Microbiology related SOPs, Methods, Laboratory oversight;
• Responsible for training for all the personnel of the Micro lab;
• Manages ECVR with operations and engineering to assure timely resolution, accurate and appropriate documentation of the ECVR up to the follow up and closure;
• Escalates all events that impact the environmental conditions of the laboratory, production area or quality of the product;
• Coordinates and performs the documentation review of the data generated by the QC Techs for the Microbiology laboratory;
• Indirect supervision of the Micro lab personnel;
• Review of validation protocols to cover all the aspects and support by the Micro lab activities;
• Investigator for Micro lab related events.

Requirements:

• Bachelor or Master Degree in Microbiological, Biochemical, Quality Engineering, Engineering Sciences or Chemistry;
• Knowlegde of Process Validation, Equipment Qualification (including Computerized Systems) and Statistical Knowledge, cGMP Knowledge, Excellent technical Writing skills in English;
• Strong oral, report and writing skills in English.

Experience:

• A minimum of five (5) years of experience in a similar position in Pharmaceutical or Biotechnological Related Industry; preferred with a minimum of two years in supervision;
• Experience in designing and developing of sterilization cycles and execution of the validation protocol for autoclave (solid and liquid goods) is a plus.

How to Apply

Please send your resume and cover letter with motivation to: [email protected] Reference check and a psychological assessment can be part of the application procedure. For more information or other queries please contact Yvette White on : (+5999) 7376014 or E:[email protected]

Job Categories: Medical. Job Types: Full-Time.