HRINC (Cambodia) Co., Ltd

Quality Assurance

GeneralPosted 1 mo ago

Location

Phnom Penh

Job Type

FULLTIME

Experience level

Mid-Senior

Work Mode

On-site

Industry

Real Estate and Equipment Rental Services

Languages

English, Khmer

About the role

Manage all regulatory submissions to MoH, DDF, and NHPQC for new registrations, renewals, variations, and product lifecycle maintenance.
Coordinate registration and renewal activities for pharmaceutical and healthcare products from EU, India, Pakistan and other approved manufacturers.
Prepare, review, and submit registration dossiers in compliance with Cambodian regulatory requirements.
Follow up on submitted applications until approval is obtained.
Manage product labeling updates, packaging changes, company name changes, and other regulatory variations.
Prepare and coordinate package insert translations in accordance with regulatory requirements.
Ensure timely renewal of company, warehouse, and other regulatory licenses.
Obtain import permits from MoH and coordinate with Health Authorities for shipment clearance.
Support marketing activities by obtaining approvals for promotional materials, social media content, round table meetings, and other promotional events.
Coordinate with regional and global Regulatory Affairs teams to ensure timely submission of high-quality applications.
Provide regular regulatory status reports, milestone updates, and compliance reports to management.
Build and maintain strong regulatory nets with relevant authorities and stakeholders.
Perform other duties assigned by management.
Develop, review, implement, and maintain SOPs, guidelines, and quality documents.
Ensure all SOPs and quality documents are updated and aligned with current practices and regulatory requirements.
Conduct SOP and quality-related training for relevant departments.
Perform self-inspections and internal audits, particularly in warehouse operations, to ensure compliance with SOPs and guidelines.
Monitor and enforce adherence to quality systems, procedures, and regulatory requirements.
Investigate quality issues, deviations, and non-conformities, and implement corrective and preventive actions (CAPA).
Maintain quality records and documentation in compliance with company and regulatory requirements.

Requirements

Bachelor's or master's degree in pharmacy (B.
Pharm / M.
Pharm) — strongly preferred.
Sc. in Life Sciences / Biotechnology with relevant regulatory experience also considered.
Post-graduate diploma or certification in Regulatory Affairs (e.g., RAPS, IAPS) is a distinct advantage.

Required Skills

PharmacyLife SciencesBiotechnologyRegulatory AffairsB. Pharm / M. PharmB.Sc. in Life Sciences / BiotechnologyPost-graduate diploma or certification in Regulatory AffairsRAPSIAPS

About HRINC (Cambodia) Co., Ltd

Visit Website

HRINC is the leading provider of HR Services to the Cambodia market and expanding to the South East Asia region. We support multinational companies and leading ASEAN conglomerates and SMEs with their Human Resource needs, from consulting and market intelligence, to outsourcing and compliance as well as recruitment.

Industry

Real Estate and Equipment Rental Services

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About the role

Manage all regulatory submissions to MoH, DDF, and NHPQC for new registrations, renewals, variations, and product lifecycle maintenance.
Coordinate registration and renewal activities for pharmaceutical and healthcare products from EU, India, Pakistan and other approved manufacturers.
Prepare, review, and submit registration dossiers in compliance with Cambodian regulatory requirements.
Follow up on submitted applications until approval is obtained.
Manage product labeling updates, packaging changes, company name changes, and other regulatory variations.
Prepare and coordinate package insert translations in accordance with regulatory requirements.
Ensure timely renewal of company, warehouse, and other regulatory licenses.
Obtain import permits from MoH and coordinate with Health Authorities for shipment clearance.
Support marketing activities by obtaining approvals for promotional materials, social media content, round table meetings, and other promotional events.
Coordinate with regional and global Regulatory Affairs teams to ensure timely submission of high-quality applications.
Provide regular regulatory status reports, milestone updates, and compliance reports to management.
Build and maintain strong regulatory nets with relevant authorities and stakeholders.
Perform other duties assigned by management.
Develop, review, implement, and maintain SOPs, guidelines, and quality documents.
Ensure all SOPs and quality documents are updated and aligned with current practices and regulatory requirements.
Conduct SOP and quality-related training for relevant departments.
Perform self-inspections and internal audits, particularly in warehouse operations, to ensure compliance with SOPs and guidelines.
Monitor and enforce adherence to quality systems, procedures, and regulatory requirements.
Investigate quality issues, deviations, and non-conformities, and implement corrective and preventive actions (CAPA).
Maintain quality records and documentation in compliance with company and regulatory requirements.