QA Manager - Pharmaceutical/Medical Industry

Job Scope

• 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 AURIGA CARE 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.

Hurry if you are the one we are seeking for kindly send your resume at this email [email protected] for a quick chat!!!

Job Type: Full-time

Pay: RM8,000.00 - RM10,000.00 per month

Schedule:

• Monday to Friday

Experience:

• Pharmaceutical or Medical: 10 years (Required)
• Auditing: 1 year (Required)