QA Manager (Pharma/ Medical Devices)
Key Responsibilities
To act as Quality Liaison personnel in ensuring the Quality Management System are being exercised and implemented as per regulatory requirements (ISO9001:2015, ISO13485:2016, GMP, GDP, GDPMD) and Principal Requirements.
Job Descriptions:
· Develop and implement Quality Management System (QMS) as per requirements (ISO 9001:2015, ISO 13485:2016, GDP, GMP, GDP and GDPMD) and customer/principal requirements.
· Coordinating company Annual Management Review Meeting (MRM) and follow – up identified action required after the meeting.
· Develop, Review and Maintain the company adherence to SOPs, WIs and Forms as per Quality Management System (QMS) requirements.
· Oversee and ensure the Non-Conformance is log timely, reviewed and close with effective action taken.
· To oversee and ensure the customer complaint is log timely in the software, reported and close timely.
· To oversee and ensure Corrective Action and Preventive Action (CAPA) are taken with effective measures.
· Coordinate and maintain the Training Program sitewide as per internal SOP, regulatory requirements and principal requirements.
· Monitor external Service/Product provider performance as supplier Management Program.
· To oversee and ensure Supplier Corrective Action Report (SCAR) are taken with effective measures.
· To lead and coordinate Internal Audit Program activities as per requirement (ISO 9001: 2015, ISO 13485:2016, GDMPD, GDP/GMP)
· Lead and Coordinate External Audit from Authority, Principal and CAB as per requirement (ISO 9001, ISO 13485, GDMPD, GDP/GMP)
· Lead and coordinate the Change Control Program as per internal SOPs and requirements (ISO9001:2015, ISO13485:2016, GMP, GDP, GDPMD Principal Requirements).
· Lead and Coordinate Temperature Mapping Program as scheduled and according to requirements (GDP)
· Lead and Coordinate Validation and Qualifications Program as scheduled and according to requirements (GDP)
· Lead and Coordinate Redressing and / or Relabeling for Pharmaceutical and Medical Devices Product
· Lead and coordinate new and/or potentially Customer and Principal Integration and Migration
· To assist incoming product release (pharmaceutical and Medical Devices) as per requirements.
· To prepare and approved incoming product redressing / relabeling (pharmaceutical and Medical Devices) as per requirements.
· To review and approved monthly services report of Pest Control, Temperature Recording, Facility cleaning and Monitoring.
· To review and verify 3PL redressing, product return and NFHU conversion as per principal requirement.
· To review new and/or existing Quality Technical Agreement with Principal as per principal requirement
· To be contact personnel for liaise with Principal regarding any changes, audit, meeting, documentation and request according to principal requirement
· To attend the monthly Country Business Review reporting departmental KPI, risk and compliance as per requirement ISO9001:2015, ISO13485:2016, GMP, GDP, GDPMD Principal Requirements).
· Develop and foster strong professional relationships with regulatory authorities and professional bodies.
· Provide insight and advice on all activities or matter associated with Quality Assurance System, Medical Affairs and Pharmaceutical compliance of the company.
· Supervising and providing technical support and guidance to Operation Department for Quality Assurance matter related.
· To participate and assist during annual Regulatory Affairs department Precursor Audit by Authority (NPRA)
· To plan and conduct the Pharmacovigilance Audit to Regulatory Affairs department annually according to requirement (QMS and GVP)
a) Minimum Requirement
· Work experience in the Pharmaceutical and/or Medical Devices industry for a minimum of 10 years.
· Managing role experience for a minimum of 2-3 years.
· Knowledge on QMS (ISO 9001:2015, ISO 13485:2016, GDPMD, GDP/GMP)
· Auditing experience in Pharma and MD
· Lead Auditor certified (IS0 9001: 2015) or GDP would be added advantage.
Job Types: Full-time, Permanent
Pay: RM5,000.00 - RM12,000.00 per month
Experience:
- ISO 13485: 3 years (Required)
