QC Expert

QC Expert (Lab Validation/ Decommissioning/ Pharma)

Location : Gul Circle

Salary up to $7,000 depending on experience

Industry : MNC Pharmaceutical

Our clients deliver 4.3 billion healthcare solutions annually and with your talent, we can do even more to protect and support patients

Responsibilities

• Being representative of the site in the CoPs led by the global, for the process in his/her scope, and if requested participating in the CoEs, and ensuring local communication.
• Maintaining the site validation master plan and procedures related to ALCM and CPV of GXP laboratory equipment and ensuring alignment with site Quality &Validation strategy.
• Support annual method review in the framework of annual product review.
• Support the invalid assay trending program in the QC laboratory.
• Lead compendial compliance assessment and adherence for the QC laboratory.
• Lead periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate.
• Ensuring implementation and maintenance of QC digital solution (core model and local) (including data management and end-user management).
• Ensuring all the life cycle management of the QC lab equipment, including management of obsolescence risks and anticipating capacity needs.
• Establishing metrics and monitoring data for the qualification activities, to identify trends and issues, during life cycle management of the lab equipment.
• Overseeing the execution of qualification and maintenance operations related to QC equipment of the quality control laboratory to ensure adherence to the committed scheduled plans.
• Ensuring all QC equipment are properly qualified and maintained for their intended use.
• Assume role of SME for Labware LIMS and collaborate closely with global site functions to address changes
• Ensuring the compliance of laboratory GXP asset qualification and maintenance with applicable regulatory requirements and company quality standards.
• Ensuring the proper documentation, issuance, review, and approval of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
• Providing support during regulatory inspections and audits by presenting equipment management and Method validation documents and record.
• Leading initiatives for continuous improvement in QC support processes related to lab equipment management.
• Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities.
• Ensuring laboratory instruments and facilities are kept in a quality and safety status to ensure that they can be used appropriately.
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
• Participate in Change Control Request facilitation and management in relation to QC test methods.
• Provide technical leadership and guidance for the successful completion of major laboratory projects.
• Provide technical system administrator support for QC GXP laboratory computerized systems.
• Deputized QC Manager as required.
• Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and HSE aspects
• Ensure compliance with HSE and quality policies and site procedures. Ensure safe working in the laboratory by practicing and communicating safety.
• Play a pro-active role in ensuring the HSE standards & Life Savings Rule are adhered to. Embrace Zero Incident Mindset and adopt the responsible of HSE protection policies and Life Saving Rules (LSR). Practice safe laboratory operations and ensure all HSE procedures are followed.
• Other responsibilities that are not included in the above but are related to quality control and in accordance with internal guidelines and SOP.

Requirements:

• University Degree in relevant scientific discipline
• 5 years of experience in
  quality control within pharmaceutical
  with knowledge of Good Manufacturing Practices (
  GMP
  ), regulatory requirements and expertise on
  lab instruments
  .
• Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements as well as quality systems and associated technologies .
• Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement.
• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
• Good understanding of
  Good Laboratory Practices
  ,
  Good Documentation Practice
  and data integrity requirements.
• Experienced in
  analytical method continuous monitoring requirements
  .
• Excellent interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.
• Independent, discipline and assertiveness in decision-making and execution in laboratory activities.
• Good communication skills to advocate QC positions with other functions, including during inspections.
• Continuous improvement mindset.

Lim Pey Chyi -

Recruitment Consultant (R

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

Desired Skills and Experience
University Degree in relevant scientific discipline

5 years of experience in quality control within pharmaceutical with knowledge of Good Manufacturing Practices (GMP), regulatory requirements and expertise on lab instruments.

Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements as well as quality systems and associated technologies .

Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement.

Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.

Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.

Good understanding of Good Laboratory Practices, Good Documentation Practice and data integrity requirements.

Experienced in analytical method continuous monitoring requirements.

Excellent interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.

Independent, discipline and assertiveness in decision-making and execution in laboratory activities.

Good communication skills to advocate QC positions with other functions, including during inspections.

Continuous improvement mindset.

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

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