Lowongan Product Quality Assurance Supervisor di PT Bayer Indonesia

JOB PURPOSE

• To support the QA operation manager and as the Subject Matter Expert (SME), coordinator or the executor of the implementation Product Quality Review (PQR), corrective action/preventive action (CAPA) management, handling SAP QM and BOM management following valid SOP.
• To ensure the compliance implementation of the Bayer and Authority regulations related with those aspects

YOUR TASKS AND RESPONSIBILITIES

• Responsible to coordinate handling of PQR (Product Quality Review) and scheduling execution of PQR.
• Provide PQR report on every reporting year (January of following year) by reviewing batch records, reviewing the results of assay testing and critical-in process control parameter, reviewing the process capability index of each results, reviewing complaints, deviations, OOS, Non-conformity, stability study, changes, process validations report following valid SOP that notified in PQR period review.
• Responsible for monitoring and follow up Corrective Action/Preventive Action (CAPA) from deviation, complaint, PQR, and OOS. Perform regularly meeting to follow up open CAPA and check the CAPA effectiveness for major or critical discrepancy.
• Responsible for reviews specifications.
• Act as deputy to approve specifications on behalf of QA Operation Manager.
• Responsible to perform QA review for Bill of Material (BOM) initiation or revision in SAP system and perform activation/deactivation of the BOM.
• Responsible on handling archiving batch record.
• Responsible to manage monthly report related Product Quality Assurance Area
• Act as local process owner for SAP QM and Trackwise system (for Self-Inspection) and ensure the data integrity compliance and validated status of both system.
• Perform execution on quality management system task in product quality assurance area.
• Upgrade his/her-self in management and professional skills and support developing team especially on GMP aspects.
• All activities related job functions must be considering the OE culture and reducing complexity in QA Operations area.

WHO YOU ARE

• Bachelor’s degree in pharmacy and having apothecary degree  
• Experiences 2 years in QA function
• Having exposure to QA/GMP compliance or manufacturing at a pharmaceutical manufacturer.
• Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes). Be familiar with BHC GMP Policies and Directives through training to enable controlling implementation into local practices.
• Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
• Skilled to work within an international team and has ability to work within team.
• Having a good problem-solving skill
• Skilled to work within an international team and ability to work within teams.
• Having good Leadership experience.
• Having Good organizational and time management skills
• Professional English skills.
• Able to resist any influence, which would hamper management decision making during the absence of QA Operation Manager.
• Having high motivation to learn a new thing
• Having good writing and communication skill both in English and Bahasa
• Having good skills on teach the member.