ClinChoice Hiring Quality Assurance Specialist
Position Title: Quality Assurance Specialist
Company Name: ClinChoice
Salary: Competitive, commensurate with experience
Company Address: Bengaluru, Karnataka, India (On-site)
Detailed Job Description:
Role: Quality Assurance Specialist
Industry Type: Pharmaceutical
Department: Quality Assurance
Employment Type: Full-Time, On-site
Role Category: Compliance and Quality Management
Education:
- UG: Not specified
- PG: Not specified
Key Skills: Quality Assurance, Nonconformance Management, GCP, GVP, Stakeholder Management, Pharmaceutical Compliance, Communication Skills
Job Description:
As a Quality Assurance Specialist at ClinChoice, you will play a vital role in maintaining and improving our quality and compliance standards in the pharmaceutical industry. Your primary responsibilities will include:
- Performing QA functions related to Change Management, CAPA (Corrective and Preventive Actions), Deviations, Internal Audits, External Audits, Risk Management, Innovation, and Continual Improvement.
- Understanding and implementing GXP requirements such as GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice), GMP (Good Manufacturing Practice), GDocP (Good Documentation Practice), and monitoring them for the QA function as applicable.
- Facilitating the initiation of investigations and CAPAs, monitoring progress, and performing reviews/approvals.
- Ensuring that CAPA procedures and requirements are followed and met, upholding standards for quality and compliance in pharmacovigilance.
- Escalating and involving stakeholders in resolving issues that impact progress toward completing investigations, root cause analysis, impact analysis, and closure of CAPA records.
- Reviewing evidence and approving closure of CAPA plans and effectiveness monitoring plans.
- Facilitating regular CAPA status and metric reports to ensure senior management awareness.
- Participating in governance/oversight activities, including trend assessment and other quality reviews.
What We Look For:
- Experience in Quality Assurance functions, with a strong understanding of GXP requirements.
- Proficiency in Nonconformance Management, including CAPA and Deviations.
- Knowledge of GCP and GVP.
- Excellent stakeholder management skills.
- Outstanding communication skills are a must.
How to Apply:
If you are a dedicated professional with a passion for quality assurance and compliance in the pharmaceutical industry, we encourage you to apply for this position. To express your interest, please refer to the job post above and submit your resume to saba.naaz@clinchoice.com.