Analytical Manager Pharmaceutical - Cikarang - WFO (ID: 707649)

Key Responsibilities:

• Lead daily analytical laboratory operations, ensuring timely testing and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.

• Develop, validate, transfer, and continuously improve analytical methods to support product lifecycle management and manufacturing excellence.

• Ensure compliance with cGMP, GLP, BPOM, and applicable international quality standards through effective laboratory governance and documentation.

• Lead investigations for Out of Specification (OOS), Out of Trend (OOT), laboratory deviations, and CAPA implementation to ensure robust root cause resolution.

• Partner closely with Production, Quality Assurance, Regulatory Affairs, R&D, Supply Chain, and Engineering to support manufacturing performance and product quality.

• Drive laboratory excellence through process optimization, digitalization, equipment qualification, and continuous improvement initiatives.

• Prepare and support internal, customer, and regulatory audits while ensuring laboratory inspection readiness at all times.

• Develop, coach, and inspire the analytical laboratory team, fostering a high-performance culture focused on quality, operational excellence, and continuous learning.

• Monitor laboratory performance through key quality and operational metrics, ensuring efficient resource utilization and achievement of departmental objectives.

Requirements:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.

• Proven experience leading analytical laboratories within the pharmaceutical manufacturing industry.

• Minimal 5 years of experience in related field. 

• Strong knowledge of analytical instrumentation (HPLC, GC, UV-Vis, FTIR, dissolution, etc.), analytical method validation, and pharmaceutical quality systems.

• Solid understanding of cGMP, GLP, BPOM regulations, and international pharmaceutical standards.

• Strong leadership, problem-solving, stakeholder management, and continuous improvement capabilities.
  

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