Quality Control

PURPOSE

• As Subject matter Expert (SME) related with the Quality Control (QC) activities, and as deputy of Responsible Pharmacist (QP) for QC in Bayer Cimanggis site refers to approved letter of appointment.
• Assist QC General Lead to perform review, scheduling, supervision, and analysis properly and correctly following defined rules in the purpose of implementation Bayer and Authority regulations related to the Quality Control areas.

MAJOR TASKS & RESPONSIBILITIES

1. Ensure the daily activity to be performed effectively and efficiently accordance with current regulations, such as current Good Manufacturing Practice (cGMP) principles, current Good Laboratory Practice (cGLP) principles, Good Documentation Practices (GDP), SHE (Safety, Health, and Environment) principles, food safety, halal system, regulations as specified by local FDA (BPOM = Badan Pengawasan Obat dan makanan), and country regulations from each market.
2. Responsible for performing investigation related to quality of product (deviation, OOS (Out of Specification), OOT (Out of Trend), OOL (Out of Limit), material Non-Conformity (material NC), and other non-conformity management work process), provide investigation result, documentation, and manage timeline to perform investigation.
3. Together with QC General Lead, responsible for QC capacity management to handle inspection and supervision during commercial testing (material, product, stability, environmental monitoring, validation and analytical method transfer) by ensuring that the processes are conducted according to the established procedures, QC test scheduling prioritization, and ensure related documents are available in timely manner.
4. Responsible for arranging QC testing that are performed in 3rd party laboratory.
5. Responsible to ensure testing, administrative task, reporting stability sample of commercial product include On Going Stability (OGS), commercial validation, post market stability study, stability of feasibility product that are still under responsibility of Cimanggis Plant.
6. Responsible for QC inventory management (reagent, reference standard and laboratory supplies) and coordinating purchase order by providing purchasing plan to prevent out of stock and ensure transparency in term of financial aspects.
7. Responsible for evaluation of global CMS (Compliance Management System) implementation; create SOP; ensure SOP in the area are valid, correct and updated (including reconciliation); and provide monthly KPI report including SQMR (Site Quality Management Review).
8. Responsible for arranging QC personnel qualification matrix management, training QC laboratory analysts, qualification for helper in QC, and comparative for analyst qualification.

SKILLS & REQUIREMENT

• Certified Pharmacist (are preferred), Bachelor/ Diploma degree on any fields preferably chemistry/ microbiology or having high school background on chemistry/microbiology.
• Having experience 3 years minimum in supervisory level.
• Excellent leadership skills and capability.
• Able to work on shift model ((if required).
• Ability to read, analyze and interpret Bayer guideline and international/ global guideline, writing report, business correspondence and procedure manual in English.
• Ability to manage good work atmosphere among internal team and with other teams.