Quality Assurance Manager – ISO Specialist
About the job
We are looking for a Quality Assurance Manager with 3-5 years’ experience to join our experienced team! This is an excellent opportunity for someone who has a keen interest in Quality Assurance within Pharmacovigilance.
PharSafer® is a specialist Pharmacovigilance & Medical Service CRO, headquartered in the UK, with offices also in India and Europe. As part of our commitment to uphold the highest standards of quality and compliance, we are seeking a Quality Assurance Manager with extensive ISO experience to be based in India. This role is home based and, whilst based remotely, you will join a team that span across both UK and India offices.
As a Quality Assurance Manager, you will play a key role in achieving complete compliance for our clients, ensuring that our processes and systems meet international ISO standards, including ISO 9001, ISO 13485, and ISO 27001, with a range of responsibilities including:
Responsibilities:
- Ensure strict adherence to ISO 9001, ISO 13485, and ISO 27001 standards, as well as applicable regulations and standard operating procedures (SOPs).
- Identify compliance gaps specifically related to ISO standards and collaborate with the team to develop corrective and preventive actions (CAPAs).
- Lead audit preparedness activities for ISO certifications and manage the internal audit process.
- Assist with external ISO audits and coordinate with auditors to ensure compliance with ISO requirements.
- Participate in the development, review, and revision of SOPs and quality documentation to align with ISO standards.
- Provide training and support to team members on ISO compliance and quality-related topics.
- Work collaboratively with cross-functional teams to enhance processes and maintain high-quality standards across the organisation.
Qualifications & Skills:
- Bachelor's or Master's degree in pharmacy, life sciences, or a related field.
- Proven experience in a Quality Assurance role with a strong focus on ISO standards implementation and management.
- Detailed knowledge of ISO 9001, ISO 13485, and ISO 27001 standards and their application in a pharmacovigilance or medical services environment.
- Exceptional attention to detail and a proven track record of identifying and resolving compliance issues.
- Strong communication skills, with the ability to effectively convey information to all stakeholders.
- Ability to work independently and collaboratively in a remote environment, with a high degree of self-motivation and organisational skills.
Apply Now
If you are interested in this opportunity, please submit your CV and a cover letter highlighting your experience and suitability for the role.
*Please note that there will be several stages of the recruitment process.
**Due to the volume of responses anticipated, should you have not received a response to your application within 4 weeks then please assume your application has been unsuccessful on this occasion. PharSafer® regret that we are unable to provide individual feedback on applications made.
This is a career opportunity, not a job opportunity.
We look forward to hearing from you!
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