Manager, Quality Control

MYFutureJobs; Nilai; On-site; MYR 50,000 - 90,000; Full time

Job summary

Join a forward-thinking company as a Quality Control Specialist! In this role, you will ensure compliance with GMP and GLP standards while maintaining laboratory instrumentation and documentation. You will train new employees and conduct investigations in a dynamic environment. This position offers an exciting opportunity to contribute to quality control in the pharmaceutical industry, where your expertise will help maintain the highest standards of product quality. If you are passionate about quality assurance and ready to take your career to the next level, this is the perfect opportunity for you!

Qualifications

• Minimum 8 years of experience in Pharma, FMCG, or Healthcare industries.
• Hands-on experience with QC instruments and troubleshooting.

Responsibilities

• Maintain GMP/GLP documentation and laboratory instrumentation.
• Train new employees and conduct training sessions.
• Review and approve SOPs and validation protocols.

Skills

GLP and QMS knowledge

HPLC

GC

UV

Troubleshooting skills

Technical skills in atomic absorption spectrometry

Experience in investigations and proposing CAPAs

Education

Degree in Biochemistry

Tools

Empower software

QC instruments

Job description

Key Responsibilities:

• Observe and follow all rules, regulations, and procedures in the QC Laboratory.
• Participate in in-house and external training sessions arranged by the company.
• Train new employees in the QC Laboratory.
• Maintain GMP/GLP documentation relevant to assigned duties.
• Maintain laboratory instrumentation required for testing.
• Prepare Method validation, Method transfer, Method verification, PQ protocol, and reports.
• Review test data, calibration data, and report deviations to the supervisor.
• Make usage decisions for Raw materials and packing materials in SAP.
• Procure chemicals, standards, columns, and maintain inventory for routine analysis.
• Plan samples for analysis, including Raw materials, Excipients, packing materials, In-Process, Finished Goods, Microbiology, Stability, water, and miscellaneous samples.
• Ensure stability samples are loaded and pulled out as per schedule.
• Maintain calibration and preventive maintenance schedules and ensure activities are completed on time.
• Review logbooks, work allotments, and analytical activities.
• Keep the laboratory clean and organized.
• Conduct investigations and participate in incidents, OOS, OOT, and deviations in the Physio-chemical lab.
• Initiate and close change controls and CAPA.
• Review and approve Standard Operating Procedures, validation protocols, reports, Standard Testing Procedures, and Specifications.
• Prepare Master Record of Analysis (ROA) and User Requirement Specifications.
• Review trending data for water testing and environmental testing.
• Monitor chemicals, standards, reagents, and inventory in the QC Laboratory.
• Participate in qualification and calibration of instruments and equipment.
• Monitor temperatures of incubators, refrigerators, and cooling cabinets.
• Conduct training sessions.

Qualification and Experience:

• Minimum Degree in Biochemistry.
• At least 8 years of relevant experience in Pharma, FMCG, or Healthcare industries.
• Knowledge of GLP and QMS in pharmaceutical quality control and GMP requirements.
• Hands-on experience with QC instruments such as HPLC, GC, UV, KF, FTIR, and troubleshooting skills.
• Experience working in an Oncology manufacturing plant environment.
• Experience in a USFDA-regulated environment.
• Technical skills in atomic absorption spectrometry, gas chromatography, and particle size analysis.
• Experience in investigations and proposing CAPAs for notifications like Lab incidents, OOT, and OOS.
• Proficient in handling Empower software and audit trail reviews of chromatographic and standalone instruments.

Apply now to be part of our exciting journey! If you’re ready to take the next step in your career, we’d love to hear from you! Send your resume to [e-mail]