Senior Compliance Quality Specialist Position Available
2 weeks ago
Job Title: Quality Systems Professional
">- This is a pivotal role within our organization, responsible for maintaining the site’s compliance with operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
Responsibilities:
- Maintain site quality systems including deviations, CAPA, change control, audits, customer complaints, and quality risk management.
- Review and approve documents such as failure investigations, change control documents, corrective/preventative action documents, standard operating procedures, and ensure compliance with company policy and local and international regulatory requirements.
- Monitor and trend metrics associated with site quality systems.
- Participate in continuous improvement initiatives, regulatory and customer audits, quality risk assessments, and collaborate with functional departments to resolve issues and maintain compliance.
- Identify gaps in systems and develop feasible plans for correction.
- Train personnel on quality system processes.
Required Skills and Qualifications:
- Bachelor's degree in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in pharmaceutical or related industry.
- Proven experience in conducting on-site investigations and analysis (GEMBA walks).
- Able to identify and address operational inefficiencies.
- Track record of implementing process improvements based on findings from direct workplace engagement.
- Demonstrate respectful behavior at all times.
- Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
Benefits:
We offer an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
About Us:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Contact Us:
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for us to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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