We are looking for an Asst. Manager for RA/QA who can drive implementation of the Quality Management System (QMS) by designing processes, performing audits, providing training, ensuring best practices as per Good Distribution Practices (GDP), and liaising with State FDAs and CDSCO for various submissions.
Job Responsibilities:
- Coordination with Warehouse Managers (WM) to ensure adherence to QMS.
- Handle document control and change control activities as per QMS requirements (ISO 13485:2016, 21 CFR 820 & ISO 9001:2015).
- Assess the impact of changes on product/process quality.
- Conduct Internal Quality Audits across all sites (virtually and/or physically), identify gaps, and manage CAPA processes.
- Take the lead in assisting External Auditors by explaining processes and providing the necessary documents.
- Ensure customer complaints and audit findings are resolved in a timely manner.
- Coordinate with all departments for training and development activities.
- Review trends to ensure appropriate environmental conditions and a pest-free environment.
- Prepare FDA-related documents for clients, liaise with clients' RA teams to collect required documents, submit them to the FDA, and follow up with officials/consultants to ensure timely approvals.
Qualification:
- Bachelor's Degree in Science, Pharmacy, or Business Administration.
- Certification in Quality Audit/ISO will be an added advantage.
Requirements (Skills & Qualities):
- Extremely strong work ethic and morals.
- Proven work experience in a similar role.
- Expertise in Quality Management industry standards.
- Knowledge of Good Distribution Practices (GDP).
- Training skills.
- Strong attention to detail.
- Expertise in managing internal audits and designing systems for continuous improvement.
- Ability to implement process improvement initiatives.
- Knowledge of warehouse management procedures.
- Experience working with Government FDA/CDSCO portals.
- Excellent communication skills.
- Language proficiency: English, Hindi, Marathi, and Gujarati.
Experience:
- Minimum 5 years of experience in a similar role in a Medical Device or Pharmaceutical Company.
Pay: ₹40,000.00 - ₹50,000.00 per month
Work Location: In person
