The QARA Executive (Pharmacist) is responsible for supporting Quality Assurance and Regulatory Affairs functions, including managing the controlled drug inventory in compliance with Singapore regulations. The role requires the candidate to be a registered pharmacist in Singapore and ensures adherence to GMP, ISO standards, and regulatory requirements.
Duties & Responsibilities:
Quality Assurance (QA) Support:
- Assist in reviewing QA documentation, SOPs, batch records, and environmental monitoring data.
- Support CAPA investigations, trending, and effectiveness checks.
- Assist in audits, inspections, and follow-up actions.
- Support calibration and preventive maintenance record reviews.
- Assist in developing training materials and conducting gap analyses for QA processes.
Regulatory Affairs (RA) Support:
- Prepare regulatory dossiers and license applications for products.
- Assist in regulatory submissions, post-market surveillance reports, and BCIP/IVDR compliance.
- Maintain knowledge of local and international regulatory requirements.
- Collaborate with cross-functional teams for timely regulatory approvals.
Controlled Drug Management:
- Receive, store, and manage controlled drug inventory according to regulatory requirements.
- Ensure compliance with documentation, tracking, and reporting obligations.
- Support audits or inspections related to controlled drugs.
General Responsibilities:
- Support documentation control, review, and filing for QA and RA records.
- Assist in cross-functional projects and other duties as assigned.
Requirements:
- Registered Pharmacist in Singapore.
- Bachelor's degree in Pharmacy or Life Sciences or any science-related field.
- Preferably with 1 to 3 years experience in QA and/or RA in pharmaceutical or biotech industry.
- Knowledge of GMP, ISO standards, and regulatory frameworks.
- Strong attention to detail, organizational skills, and multitasking ability.
- Proficient in Microsoft Office good communication and interpersonal skills.
- Fresh graduates and retirees are welcome to apply.
