Senior Officer, Pharmacist

SUN PHARMA; Sungai Petani; In loco; MYR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

SUN PHARMA is seeking a qualified Pharmacist to oversee documentation and compliance for the production department in Malaysia. The role requires management of psychotropic and controlled items, SOP revisions, and adherence to GMP standards.

You will support training, organizational chart updates, and production documentation workflows. The ideal candidate will coordinate CAPA, Change Control and deviations in Trackwise, update URS and LMS records, and supervise subordinates while ensuring

Competenze

• Registered Pharmacist with Poison License A.
• Experience in managing psychotropic and controlled items in a production plant.
• Assist Manager and Production Dept. in documentation activities.

Mansioni

• Ensure GMP-compliant documentation across production.
• Revise SOPs in EDMS and execute them in production.
• Handle CAPA, Change Control, Deviation, PQC and OOS investigations in Trackwise.
• Prepare URS for the production department.
• Update LMS activities per LMS guidelines.
• Monitor subordinates and provide necessary guidance.
• Oversee hologram and scheduled waste management.

Conoscenze

Registered Pharmacist

Formazione

Poison License A

Strumenti

EDMS system

Trackwise

LMS

Descrizione del lavoro

• Responsible to ensure all operation of production is in comply with GMP Guidelines & Poison Act 1952.
• Responsible to ensure production activity is not interrupted due to interrelated with documentation matters.

Essential Job Functions:

• A Registered Pharmacist and Poison License A Holder.
• In charge of psychotropic and controlled item management in plant.
• To assist Manager and Executive in all documentation activity related to production department.
• Responsible to assist Department Training Coordinator (DTC) of Production Department.
• To ensure training are conducted to production personnel within required timeline.
• To prepare and update Production Organization Chart when required.
• To prepare and update job description (JD) of production personnel when required.
• To ensure all documentation adhere to GMP compliance.
• Responsible for SOP revision in EDMS system and execution within production.
• Responsible for handling CAPA, Change Control, Deviation, PQC Investigation and OOS investigation related to production concerned in Trackwise system.
• Responsible to prepare URS for production department.
• Responsible for updating LMS activity as per GSUM000004 “User Manual (UM) Learning Management System (Administrator Mode)”.
• To monitor the work of subordinates and ensure the necessary assistance is provided to them for their timely, adequate and accurate completion of the assigned work.
• Responsible for monitoring of hologram management.
• Responsible for monitoring of scheduled waste management.