Deskripsi Pekerjaan
Are you a seasoned Quality Control professional ready to lead and ensure the highest standards of pharmaceutical excellence? Roi Surya Prima Farma is looking for a highly capable Manager QC to join our team in Pandaan, East Java. In this pivotal role, you will be responsible for overseeing the Quality Control department, ensuring that all production processes strictly adhere to national and international regulatory standards such as CPOB (Cara Pembuatan Obat yang Baik) and CPKB (Cara Pembuatan Obat Biologi yang Baik).
As our Manager QC, you will act as the guardian of product quality and patient safety. You will lead a team of technical experts to validate analytical methods, manage batch releases, and handle critical deviations with precision. We are seeking a strategic leader who can bridge the gap between production operations and quality assurance, ensuring compliance while driving operational efficiency in a dynamic manufacturing environment.
Tanggung Jawab
- Supervise and lead the daily operations of the Quality Control department, ensuring all laboratory activities are performed in accordance with Standard Operating Procedures (SOPs).
- Ensure strict compliance with CPOB (Good Manufacturing Practice for Finished Pharmaceutical Products) and CPKB standards throughout the production lifecycle.
- Oversee the batch release process, ensuring all raw materials, in-process materials, and finished goods meet established quality specifications before distribution.
- Manage and investigate product deviations, out-of-specification (OOS) results, and complaints to determine root causes and implement corrective actions.
- Conduct internal quality audits and participate in external regulatory inspections, preparing the facility and documentation as required.
- Train and mentor QC staff, fostering a culture of quality awareness and technical proficiency within the laboratory team.
- Collaborate closely with Production and RA (Regulatory Affairs) teams to resolve quality-related issues and optimize production workflows.
Kualifikasi
- Minimum Bachelor’s degree (S1) in Pharmacy (Farmasi) from an accredited university.
- Minimum of 3-5 years of experience in a pharmaceutical Quality Control or Quality Assurance role, with at least 2 years in a managerial or supervisory position.
- Deep understanding of GMP, CPOB, and CPKB regulations, including relevant Indonesian Ministry of Health guidelines.
- Strong knowledge of analytical instrumentation (e.g., HPLC, UV-Vis, GC) and validation methodologies.
- Excellent leadership, communication, and problem-solving skills with the ability to work under pressure in a fast-paced manufacturing setting.
- Proven track record in managing laboratory teams and coordinating with cross-functional departments.