Executive Recruitment Company Monroe Consulting Group Malaysia's healthcare Division is recruiting on behalf of a leading MNC in Biotechnology, a company that innovates and revolutionizes new solutions for everyday treatment. Our esteemed client has a global presence and manufactures various pharmaceutical products to treat patients across 120 different countries. They are seeking an experienced Product Compliance Manager with expertise in cGMP, strong documentation skills, and the ability to communicate effectively and ensure regulatory compliance. The job will be based in Johor, Malaysia.
- Responsible for identification and raising deviation, change control and compiling other cGMP related documents in coordination with QA.
- To prepare, review, and revise the SOP, EOP and batch records.
- To maintain two-way communication with superior and escalate matters on timely basis for any hindrances/obstacles faced during execution of day-to-day tasks.
- To update SOP and EOP master index, organogram, logbook registration list etc.
- Report any incident or accident immediately to the superior.
- Adhere to safety, health, hygiene, and environment measures.
- Compliance with proper, accurate and timely documentation (e.g., logbooks and other relevant work specific documents).
- Adhere to cGMP and pharmaceutical guidelines.
- Support compliance team and coordinate with CFT for QMS element closure; deviation, change control and compiling other cGMP related documents in coordination with QA.
- Strictly adhered to the EHS, cGMP and defined standard operating procedures and other practices.
- Responsible in handling quality documentation of PDP related, such as deviation, change control, OOS, CAPA, SOP.
- Ensure all personal training programs and records are up to date as per training matrix.
- Bachelor's Degree in Pharmacy or any relevant certificate is mandatory.
- Registered Pharmacist with a minimum of 10 years' experience in handling statutory and regulatory risks according to the NPRA code of conduct.
- Possess excellent skills in regulatory compliance, meticulous documentation, effective communication, safety adherence, and quality management, ensuring product compliance and adherence to industry standards.