QA Support
5 days ago
We are seeking a QA Support professional to apply company service standards, maintain complaint and nonconformance tracking, manage QMS documentation, and support broader QA activities. The role focuses on Quality Assurance for Validation Services in India, ensuring these services meet established company standards. Sartorius Confidence Validation Services provides services to customers in the (bio)pharmaceutical industry with focus on validation of filter and single-use applications.
What you will accomplish together with us:
- Issue documents in accordance with established procedures.
- Review calibration, preventive maintenance (PM), qualification, and service reports and related documents.
- Support and review the closure of quality events, deviations, and OOA; contribute to investigations and CAPA.
- Maintain training and QMS records and documentation.
- Support the QA team in continuous process improvement.
- Continually review processes and systems to identify improvement opportunities.
- Report process gaps and recommend appropriate corrective and preventive actions.
- Draft, revise, maintain, and control operating procedures (SOPs).
- Help maintain compliance with applicable quality regulations and Sartorius quality standards.
- Review customer requirements related to QMS aspects.
- Help ensure Validation Services comply with local statutory, regulatory, and safety requirements.
- Support preparation for internal and external audits.
- Contribute to other QMS and safety-related activities as needed.
What will convince us:
- Master's degree in Life Sciences/Pharmacy (e.g., M.Sc. Microbiology, M. Pharm).
- 0–1 year of experience
- Knowledge of ISO standards (e.g., 9001, 14001), GDP, GLP; other quality/environmental regulations is a plus.
- Understanding of industry standards and company policies.
- Ability to prioritize and manage daily assignments.
- Strong interpersonal skills to build positive relationships with internal and external stakeholders.
- Ability to quickly assess task requirements, anticipate challenges, and communicate effectively to drive execution.
- Proficiency with Microsoft applications (Word, Excel, PowerPoint).
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