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Engineer - Validation (Technical Service)
| Institution |
Baxter BioScience, Singapore |
| City |
Woodlands |
| Country |
Singapore |
| Job Title |
Engineer - Validation (Technical Service) |
| Description |
The purpose of the job is to participate at the activities of the department « Quality Engineering » and includes in details:
- Material qualification processes
- Manufacturing Process Validation and supportive protocols
- Support to Critical systems, Cleaning validation and sterilization processes
Process Validation and material qualification:
• Participate to establishment and revision of the Master Validation Plans for manufacturing processes and material Qualification. Ensure that the validation strategy is followed as defined in the Master Validation Plans.
• Support the evaluation and define the impact on the validation of the material and process and the need for additional testing after intervention/modification in cooperation with the qualification group, as applicable.
• Participate to write Standard Operation Procedures (SOPs).
• Establish the IQ/OQ/PQ or PV according to current Good Manufacturing Practices (cGMP) and ensure that the Good Documentation Practices (GDP) are respected.
• Participate and help to execute validation protocols.
• Ensure the timely availability of the qualification/validation activities.
• Participates to and support department and facility projects.
• Support Critical systems, Cleaning Validation activities as well as Sterilization, Sanitization and Depyrogenation Processes
• Ensure that Standard Operation Procedures (SOPs) are established/modified and implemented following validations.
• Support other departments in writing of protocols. Review, summarize and prepare final reports of executed protocols.
 Responsibilities:
Support evaluation of exceptions in the area of responsibility (process)
Evaluation of results in term of acceptability to standard, procedures and regulatory requirements.
Identify and report areas of non-conformance and areas of improvements.
Identifies and reports problems in the assigned area.
Ensure appropriate communication with the management, staff and other function.
Ensure that all documents, procedure are properly completed and documented in a timely manner.
Conduct analysis of written procedures and submit procedural changes as needed to met Corporate, Divisional, and Regulatory Requirements.
Participate in internal and external assessments as required.
Assist with audits of various reports (protocols, Qualification, Regulatory submission,..).
Support process with timely closure of observations/audits items.
Ensure that all commitments are meet.
Follow and report the quality indicators of the quality system of the area.
Participate to continuous improvement using QLP.
 Quality organization support:
• Provide expert evaluation of changes within the area of responsibility
• Participate to investigation of non conformities (deviations and exceptions)
• Lead/Provide expert review of DISC / DCR / CR / CT were necessary within the area of responsibility
• Support the Quality In Operation (QO) group for solving problems.
 Re-qualification activities (collaboration with QO):
• Support the requalification activities. |
| Category |
Manufacturing |
| Keywords |
Validation |
| Education |
Degree in Biotechnology, Biochemistry or equivalent |
| Experience |
- 3 years of relevant working experience in Pharma validation or measuring technique and GDP documentation based on normative regulations and guidelines (e.g. GMP guidelines standards, SOPs, etc.)
- Diploma holders with >5 years of relevant working experience will be considered. |
| Work experience |
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| Primary Language |
English |
| Secondary Language |
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| Other Requirements |
-Good interpersonal skills to interact with process experts in the TS team
-Good leadership and communication skills |
| Reference |
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| Comments |
For more details and application of position, please visit and deposite your resume at www.baxtercareers.com.sg
Only shortlisted candidates will be notified. |
| Job created |
Jan 18, 2010 01:17:29 |
| Job last modified |
Feb 25, 2010 08:01:31 |
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