Biocon Sdn Bhd is looking for new potential candidates to fill in for Sr. Manager Quality Assurance - Computer Systems Validation position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
• Overall responsible as part of team of QA professionals for quality assurance in Engineering activities in computer systems, automated systems during Qualifications & Validations as follows.
• Responsible for review of Computer System Validation Plan and ensuring all validations are conducted as per schedules and procedures.
• Responsible for review, issuance, training, control, reconciliation, retrieval and approval of GMP documents like validation protocols, reports, Master Validation Plan / Formats I Records, Logs like GMP documents.
• Responsible for ensuring all site facilities, equipment's, instruments, utilities having computer systems are executed as perdefined schedules and procedures in accordance with cGMP (Good Manufacturing Practices) and GAMP (Good
• Automated Manufacturing Practices) standards.
• Responsible for ensuring Risk Assessment (RA) is performed for all equipment's, systems, utilities facilities for computerized systems, as applicable are executed and defined controls of GAMP requirements like audit trails, data backup, recovery storage and password protection is in place to ensure data integrity.
• Responsible for review and approval QMS documents like other department SOP's, change controls, deviation reports,CAPA verifications, QA SOPs, pertaining to CSV.
• Responsible for part of investigations team and review of CSV related investigation reports, identifying CAPA and effective monitoring for implementation.
• Participate in internal and external audits. Responsible to provide CSV related technical responses during the audit and implement appropriate action plan to be presented to the auditor. Identifying, monitoring compliance to CAPA identified asan outcome of audit observations.
• Responsible for ensuring elements of Quality Management Systems are assessed and completed as per set timelines .Perform risk assessments, impact assessments, as applicable.
• Involve In continuous improvement plans by effective quality gap analysis programs, from the learnings obtained as part of internal and external audits as well as with changes in the regulatory expectations.
• Participate In GMP rounds and reporting observations as per procedure .
• To actively participate QMS meetings with peers and superiors. Update and discuss issues, if any with the senior management in order to find an effective solution keeping product quality, safety and efficacy as the top priority.
• Responsible for supporting quality review meeting as per procedure,
• Member of Change Management and Deviation Management Panels which involves assessing the changes and deviations with the panel members, responsible for assessing the Impact of the change and deviation on CSV.
• Coordinate with Biocon India, Bangalore for harmonized CSV Procedures at Biocon Sdn. Bhd
• Participate in external training and external audits within qualification and validation scope in building better understanding, identifying aaps and be in current with validation and quality Approach
• High knowledge in 21 CFR part 11, PIC/S Annexure 11, ISPE GAMP 5 and other CSV related regulatory
• Have experience as a QA role which involves deviation investigation, change management review, CAPA and other CMS elements related to CSV and engineering
• Have high understanding in CSV lifecycle, deliverables, requirements and regulatory expectations
• Experience in prepare/review/approval of all CSV deliverables
• Have knowledge in preparing CSV Master Plan and maintaining as per requirement
• Have capabilities to identify gaps and able to promote continual improvement for site CSV activity
• Able to drive and provide solutions to achieve the expected validation deliverables within SLA
• Have skills and knowledge using Risk Assessment as a tool to define appropriate deliverables/approach for a CSV activity/project
• Experienced in validation campaign/project involving MES ,automation/PLC like system ( SCADA, ABB, DeHa V, Siemens and others related)
• Good interpersonal skills, fluent in English (written/ spoken}
• Able to work independently within job scope and deliver expected results within SLA
• Good team player, able to support team members whenever required
• Good computer skills, Microsoft applications, basic programming/database knowledge
• Understands cGMP environment and performs adequately as cGMP practice
• Any Additional Notes/ Information:
• Additional exposure/experience in paperless validation lifecycle management system will be a benefit
• Experience working in pharmaceutical like industry
The attached document speaks about the journey and the many challenges and milestones encountered along the way. It talks of the Human Capital strategy of the company and how the Malaysia story is embedded in the same.
There were several steps which led to the success and many of them were differentiated with innovative ideas and sharp business acumen.
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