Quality Compliance Lead
Quality Compliance Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 nonconformances 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 crossfunctional 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:
- Bachelors 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 problemsolving and decisionmaking skills.
- Strong written and verbal communication skills.
- Ability to work effectively in a team environment and collaborate with crossfunctional teams.
- Detailoriented with a strong focus on quality and compliance.
- Proficiency in using quality management systems (QMS) investigation tools and change management tools.
Employment Type
Full Time
