Job Summary

Are you the kind of person that is always thinking, sketching, seeking, and adjusting Who needs to understand how things work and then figure out how they can work better Are you a passionate, tenacious, solver who loves to work with others who share your drive Are you positive, constructive, and ingenious

Are you always solving

Then we d like to meet you and bet you d like to meet us.

Ashland has an exciting opportunity for a QA specialist to join our Resource Group Team at our Mumbai office. This is a very visible, significant role within the Company and the Quality division at Ambernath site (On site job). This position will report to QA/QC Manager.

The primary role of this position within the Aquarius Ambernath, India is to manage, maintain and continually improve the Aquarius Quality Management System while safeguarding alignment with applicable ISO standards, EXCiPACT and regulatory requirements, compendial requirements, Ashland objectives and customer needs. Maintains site certifications as appropriate (i.e. ISO, EXCiPACT, FSSC, Organic, Kosher, Halal etc).

Key Responsibilities

- Maintain and improve the site quality procedure.
- Valuable document management practice.
- Support ISO 9001/cGMP activities which include customer complaint management, the stability program, site cGMP validation projects, servicing customer requests, document maintenance and various data gathering/analysis.
- Establishes and maintains the quality management system.
- Customer complaint investigation
- Deviation
- SOP/ Work instruction preparation and reviews.
- Supplier Risk Assessments
- Supplier Approvals
- MOCs
- Gap Analyses/Assessments
- Internal audit
- Product Stability program
- Maintain and log new products for Halal and Kosher certification.
- Conduct internal CGMP audits.
- Preparing updating regulatory documents
- Raw material compliance




- Responding to quality and regulatory related customer inquiries
- Data integrity
- Support quality good and EHS good catches.
- New product setup in iLIMS

- Back for QC lab. Inspects output samples to verify consistent quality.
- Identifies potential sources of errors and suggests ways to eliminate them.
- Collaborates with various departments within the organization.

- Ethical Conduct: Adhere to ethical standards in research and data reporting. Avoid fabrication or falsification of data.
- Risk Assessment: Conduct risk assessments for experiments and activities to identify potential hazards and implement necessary precautions.
- Review batch records and perform final product release through iLIMS and SAP.
- OOS investigation.
- Quality Metrics monitoring.
- Raw material and finished product retesting.
- Product compliance review with respective compendial.
- New lab equipment qualification.
- Global monograph reviews
- regulatory documentation support for Drug master files regulatory intelligence support

Qualifications

- B.Sc. in chemistry or biology or equivalent years of experience.
- A minimum of 3-5 years Quality Assurance experience in a regulated industry.
- Ability to work as part of a team.
- Competency in the use of Microsoft Office Suite.
- Experience with SAP and iLIMS.
- Knowledge of Laboratory cGMP, GLP and Safety.
- Strong written and oral communication skills with ability to read, interpret, and report data.

Key Performance Indicators (KPIs)

- Audit compliance score (zero critical observations)
- Batch release turnaround time
- Deviation closure timelines
- Customer complaint closure timelines
- Right First Time (RFT) batch rate
- Customer complaint reduction

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 QA specialist (Mumbai)
🏢 Ashland
📍 Mumbai