Quality Assurance Manager
About the job
We are looking for a knowledgeable Quality Assurance Manager with experience in Pharmacovigilance to join our dynamic team! This is an excellent opportunity for someone who has a passion for Quality Assurance and wants to advance their career with a leading specialist CRO, particularly in the area of audits and inspections.
PharSafer® is a specialist Pharmacovigilance & Medical Service CRO with headquarters in the UK and offices in India and Europe. We are committed to maintaining the highest standards of quality and compliance and are looking for a Quality Assurance Manager to join our team in India. This is a remote, home-based role, where you will work closely with colleagues across our UK and India offices.
As a Quality Assurance Manager, you will play a pivotal role in ensuring our processes meet regulatory requirements and client needs. You will be responsible for maintaining our quality standards across a variety of functions, including policy development, compliance assessments, and audit management. This role not only supports audits of PharSafer® and our clients but also offers the opportunity to audit other companies as lead or supporting auditor.
Responsibilities:
- Lead or support audits, including scheduling, risk assessments, audit execution and follow up activities.
- Prepare for and conduct client assessments and manage CAPA activities.
- Oversee audit report assessments and regulatory inspections.
- Develop, review, and maintain SOPs and WPDs; provide training to staff.
- Conduct internal QA assessments and ensure compliance with current legislation and any agreed SLAs.
- Manage the impact of new regulations on PharSafer processes and coordinate any updates relating to process or training.
- Mentor junior colleagues and manage QA team workload and activities.
- Represent QA in client meetings and internal project discussions.
Qualifications & Skills:
- Degree in life sciences or equivalent experience.
- Minimum of 4 years of experience in Quality Assurance or Pharmacovigilance and a strong desire for advancement of career.
- Strong communication skills with excellent attention to detail.
- Proven leadership abilities and experience mentoring junior staff.
- Solution-oriented with the ability to manage multiple tasks and meet deadlines.
- Management experience is desirable.
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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