Biocon Sdn Bhd Vacancies Deputy Manager - Qualification Quality Assurance
Biocon Sdn Bhd is looking for new potential candidates to fill in for Deputy Manager - Qualification Quality Assurance position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
Job Description
BIOCON SDN BHD
Role/Job Description:
• Overall responsible as part of team of QA professionals for quality assurance in Engineering activities in facility, equipment, instruments, Qualifications, Calibrations and Maintenance as follows.
• Responsible for review VMP & ensuring all Engineering related Qualification are conducted as per schedules & procedures.
• Responsible for review of contamination control assessments, risk assessments of site in view of engineering controls.
• Responsible for review, issuance, training, control, reconciliation and retrieval of GMP documents like validation protocols, reports, Master Validation Plan / Formats / Records, Logs like GMP documents.
• Responsible for ensuring all site qualification for facilities, equipment, instruments, utilities, validations, calibrations, maintenance are executed as per defined schedules and procedures in accordance with cGMP (current Good Manufacturing Practices) standards.
• Responsible for ensuring Risk Assessment is performed for all engineering equipment, facilities, utilities, as applicable are executed.
• Responsible for review and approval engineering QMS documents like change controls, deviation reports, CAPA verifications, QA SOPs, pertaining to Engineering Assurance.
• Responsible for part of investigations team and review of investigation reports, identifying CAPA and effective monitoring for implementation.
• Participate in internal and external audits. Responsible to provide appropriate engineering /technical responses during the audit and implement appropriate action plan to be presented to the auditor. Identifying, monitoring compliance to CAPA identified as an 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.
• Participate in GMP rounds and reporting observations as per procedure.
• Responsible for supporting quality review meeting as per procedure.
• Member of Change Management and Deviation Management Panels which involves assessing the engineering changes and deviations with the panel members, responsible for assessing the impact of the engineering related change and deviation.
• Ensure that engineering operations, qualifications, validations are executed using approved materials and procedures, trained / qualified / certified people, validated processes, calibrated instruments.
Technical / Functional Skills:
• Proven experience in Commissioning, Qualification and Validation of Equipment, HVAC and Cleanrooms;
• Cold rooms and clean utilities qualification background is highly recommended;
• Familiarization of function and activities for Quality Control, Production, Warehouse and Environment, Health & Safety.
• Experience of pharmaceutical/ biotech regulatory compliance requirements
Behavioral / Management / Other Skills:
• Strong knowledge of QA methodologies, tools and processes
• Experience review and approval of qualification protocols and reports
• Hands-on experience with Calibrations and Preventive Maintenance activities
• In-depth understanding of technical documentation
Any Additional Notes/ Information:
• BS/MS degree in Engineering
• Proven work experience in Pharma/ Biotech Engineering QA
• Overall responsible as part of team of QA professionals for quality assurance in Engineering activities in facility, equipment, instruments, Qualifications, Calibrations and Maintenance as follows.
• Responsible for review VMP & ensuring all Engineering related Qualification are conducted as per schedules & procedures.
• Responsible for review of contamination control assessments, risk assessments of site in view of engineering controls.
• Responsible for review, issuance, training, control, reconciliation and retrieval of GMP documents like validation protocols, reports, Master Validation Plan / Formats / Records, Logs like GMP documents.
• Responsible for ensuring all site qualification for facilities, equipment, instruments, utilities, validations, calibrations, maintenance are executed as per defined schedules and procedures in accordance with cGMP (current Good Manufacturing Practices) standards.
• Responsible for ensuring Risk Assessment is performed for all engineering equipment, facilities, utilities, as applicable are executed.
• Responsible for review and approval engineering QMS documents like change controls, deviation reports, CAPA verifications, QA SOPs, pertaining to Engineering Assurance.
• Responsible for part of investigations team and review of investigation reports, identifying CAPA and effective monitoring for implementation.
• Participate in internal and external audits. Responsible to provide appropriate engineering /technical responses during the audit and implement appropriate action plan to be presented to the auditor. Identifying, monitoring compliance to CAPA identified as an 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.
• Participate in GMP rounds and reporting observations as per procedure.
• Responsible for supporting quality review meeting as per procedure.
• Member of Change Management and Deviation Management Panels which involves assessing the engineering changes and deviations with the panel members, responsible for assessing the impact of the engineering related change and deviation.
• Ensure that engineering operations, qualifications, validations are executed using approved materials and procedures, trained / qualified / certified people, validated processes, calibrated instruments.
Technical / Functional Skills:
• Proven experience in Commissioning, Qualification and Validation of Equipment, HVAC and Cleanrooms;
• Cold rooms and clean utilities qualification background is highly recommended;
• Familiarization of function and activities for Quality Control, Production, Warehouse and Environment, Health & Safety.
• Experience of pharmaceutical/ biotech regulatory compliance requirements
Behavioral / Management / Other Skills:
• Strong knowledge of QA methodologies, tools and processes
• Experience review and approval of qualification protocols and reports
• Hands-on experience with Calibrations and Preventive Maintenance activities
• In-depth understanding of technical documentation
Any Additional Notes/ Information:
• BS/MS degree in Engineering
• Proven work experience in Pharma/ Biotech Engineering QA
Company Overview
Biocon Malaysia
In 2012, with more than 40 years of success behind it, Biocon, India's largest biotech company set up their first overseas plant in Johor Bahru, Malaysia – Asia’s largest integrated Insulin manufacturing facility. With an investment of about USD 275 million, it is the highest foreign investment in Malaysia’s biotech sector till date and currently employs about 650 professionals in a state-of-the-art facility.
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.
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.
Biocon Malaysia offers an excellent career opportunity for biotech professionals.
If you want to be a part of a Company that constantly creates history and consistently earns more accollades for its innovations and other significant accomplishments and contributions, then we invite you to be a part of the BIOCON FAMILY! Apply to join us today.
How To Apply
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