Compliance Pharmacist

Key Responsibilities:

1. Regulatory Compliance - PPB &

Legal

• Licensing : Ensure company,

premises, and pharmacists have valid PPB licenses. Track renewals.

• Product Registration : Dossier

submission, variations, renewals of all products with PPB.

• Import/Export Permits : Apply for

and track permits for importation and destruction.

• Regulatory Inspections : Be the

lead contact during PPB inspections. Close all audit findings on time.

• Update on Laws : Track changes in

Pharmacy and Poisons Act, Cap 244, and all PPB guidelines.

1. Good Practices Oversight

• GDP - Good Distribution Practice :

Ensure proper storage, stock rotation, and traceability.

• GMP oversight : Liaise with

manufacturers to ensure batch records, COAs, and GMP certificates are compliant.

• Documentation : Maintain SOPs,

quality manuals, and ensure staff are trained and records are audit-ready.

3 . Internal Governance & Training

• Policy Development : Draft and

update company compliance policies to match PPB requirements.

• Staff Training : Train sales,

warehouse, and QA teams on PPB regulations, ethical marketing, and handling of poisons.

• Product Knowledge Training : Train

Sales and Marketing teams to represent products correctly and ethically to HCPs.

• Compliance Monitoring : Do internal

audits, regulatory and sales practices.

1. Risk & Reporting to Management/Managing

Director

• Compliance Dashboard : Update MD on

regulatory risks, pending PPB submissions, audit findings, and license expiry dates.

• Deviation Management : Investigate

and report any regulatory deviations with corrective actions.

• Ethical Marketing: Reviewing

promotional materials to ensure transparency, prevent misleading claims, and avoid off-label discussions.

Qualifications:

-Bachelor’s degree in pharmacy (B. Pharm)

-Valid practicing License

-Regulatory affairs and quality assurance added advantage.