Quality Compliance Lead

Job Description

This role involves coordinating of pending Deviations, Corrective and Preventive Actions (CAPAs) and Change Control. Ensures that all deviations, CAPAs, and change controls are documented, analyzed, and resolved in compliance with regulatory requirements and company standards. Responsible for leading and conducting thorough investigations into deviations within the pharmaceutical manufacturing process and QC laboratory operations. Address quality issues within the pharmaceutical manufacturing process.

Responsibilities

• Lead and coordinate investigations of deviations, non-conformances, and quality incidents in the manufacturing process.
• Conduct root cause analysis using various methodologies (e.g., Fishbone, 5 Whys, FMEA) to identify underlying issues and propose effective corrective and preventive actions.
• Document investigation findings, conclusions, and CAPAs in a clear and concise manner.
• Collaborate with cross-functional teams, including Production, Quality Control, Engineering, and Technical Service, to gather relevant information and ensure timely resolution of deviations, CAPA, and Changes Controls.
• Ensure all investigations and changes are conducted in compliance with GMP, FDA, EMA, and other regulatory requirements.
• Develop and implement CAPAs to prevent recurrence of deviations and improve overall process quality.
• Lead and manage the change control process, including the evaluation, documentation, approval, and implementation of changes.
• Conduct risk assessments and impact analyses to identify potential risks and develop mitigation strategies.
  
  

Requirements:

• Bachelor's degree in Scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience.
• Certification is preferred in quality management or related areas (e.g., Six Sigma, ASQ).
• Experience in pharmaceutical manufacturing, with at least 5 years in a quality compliance or quality assurance role.
• Strong knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
• Proven experience in conducting root cause analysis and implementing CAPAs.
• Proven experience in managing change control processes and conducting risk assessments.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills.
• Ability to work effectively in a team environment and collaborate with cross-functional teams.
• Detail-oriented with a strong focus on quality and compliance.
• Proficiency in using quality management systems (QMS), investigation tools, and change management tools.

Job Description

This role involves coordinating of pending Deviations, Corrective and Preventive Actions (CAPAs) and Change Control. Ensures that all deviations, CAPAs, and change controls are documented, analyzed, and resolved in compliance with regulatory requirements and company standards. Responsible for leading and conducting thorough investigations into deviations within the pharmaceutical manufacturing process and QC laboratory operations. Address quality issues within the pharmaceutical manufacturing process.

Responsibilities

• Lead and coordinate investigations of deviations, non-conformances, and quality incidents in the manufacturing process.
• Conduct root cause analysis using various methodologies (e.g., Fishbone, 5 Whys, FMEA) to identify underlying issues and propose effective corrective and preventive actions.
• Document investigation findings, conclusions, and CAPAs in a clear and concise manner.
• Collaborate with cross-functional teams, including Production, Quality Control, Engineering, and Technical Service, to gather relevant information and ensure timely resolution of deviations, CAPA, and Changes Controls.
• Ensure all investigations and changes are conducted in compliance with GMP, FDA, EMA, and other regulatory requirements.
• Develop and implement CAPAs to prevent recurrence of deviations and improve overall process quality.
• Lead and manage the change control process, including the evaluation, documentation, approval, and implementation of changes.
• Conduct risk assessments and impact analyses to identify potential risks and develop mitigation strategies.
  
  

Requirements:

• Bachelor's degree in Scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience.
• Certification is preferred in quality management or related areas (e.g., Six Sigma, ASQ).
• Experience in pharmaceutical manufacturing, with at least 5 years in a quality compliance or quality assurance role.
• Strong knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
• Proven experience in conducting root cause analysis and implementing CAPAs.
• Proven experience in managing change control processes and conducting risk assessments.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills.
• Ability to work effectively in a team environment and collaborate with cross-functional teams.
• Detail-oriented with a strong focus on quality and compliance.
• Proficiency in using quality management systems (QMS), investigation tools, and change management tools.