Quality Assurance Supervisor

Bahteraadijaya; Tangerang; On-site; IDR 167,400,000 - 256,680,000; Full time

Job summary

Bahteraadijaya is seeking a Regulatory Affairs professional to manage compliance programs and ensure alignment with CDOB, CPOB, CPKB, and ISO 9001 across the company in South Tangerang. The role requires collaboration with cross-functional teams to implement and socialize policies and maintain essential management system documents.

The ideal candidate will have a pharmacy degree, 3+ years in regulatory affairs, SIPA/STRA availability, and strong analytical and communication skills to interact

Qualifications

• Minimum Bachelor's degree (S1) in Pharmacy.
• Minimum 3 years in regulatory affairs handling CDOB, CPOB, and CPKB.
• Active SIPA and STRA that are currently not in use (available).
• Willing to be placed in South Tangerang.
• Understands regulations related to CDOB, CPOB, CPKB, NKV, and ISO 9001.

Responsibilities

• Create manuals and work programs for the Compliance & Regulatory department and maintain documents related to the company's management systems.
• Ensure the implementation of management systems and applicable regulations across the Company's areas.
• Socialize policies and implementation provisions of management system programs within the Company.
• Conduct periodic reporting to government agencies such as BPOM, Dinkes, BPJPH, LPPOM MUI, etc., and to certification bodies.
• Lead execution of internal, external, and customer audits within the company.
• Prepare reports and documentation of audit activities for stakeholders.
• Develop corrective action plans to prevent recurrence of issues.
• Conduct recall and traceability simulations on a periodic basis.
• Conduct supplier assessment and evaluation.
• Establish the supply chain.
• Provide training related to management systems including CDOB, CDOIB, ISO, Halal, NKV, and others.

Skills

Communication skills

Teamwork

Analytical thinking

Education

Bachelor's degree (S1) – Pharmacy

Tools

CDOB

CPOB

CPKB

NKV

ISO 9001

Job description

• Create manuals and work programs for the Compliance & Regulatory department (excluding OHS and environmental aspects) and maintain documents related to the company's management systems.
• Ensure the implementation of management systems and applicable regulations across the Company's areas.
• Socialize policies and implementation provisions of management system programs within the Company.
• Conduct periodic reporting to relevant government agencies such as BPOM, Dinkes (Health Office), BPJPH, LPPOM MUI, etc., as well as to relevant certification bodies.
• Ensure and lead the execution of internal, external, and customer audits within the company.
• Prepare reports and documentation of internal, external, and customer audit activities for relevant stakeholders.
• Develop continuous corrective action plans to prevent recurrence of issues and create better conditions in the future.
• Conduct recall and traceability simulations on a periodic basis.
• Conduct supplier assessment and evaluation.
• Establish the supply chain. 11. Provide training related to the management systems implemented by the company, including CDOB, CDOIB, ISO, Halal, NKV, and others.

Requirements :

• Minimum Bachelor's degree (S1) – Pharmacist / Pharmacy.
• Minimum 3 years of experience in regulatory affairs handling CDOB, CPOB, and CPKB (experience in NKV and ISO 9001 management would be an advantage).
• Good communication skills, able to work in a team, and analytical thinking.
• Holds an active SIPA and STRA that are currently not in use (available).
• Understands regulations related to CDOB, CPOB, CPKB, NKV, and ISO 9001. 6. Willing to be placed/based in South Tangerang.