QA Specialist

Ashland India Private Ltd

Position: QA Specialist

Job Description

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. 
• Good 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

Preferred Experience

• 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

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.
 
At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.
 
Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.
 
Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.

Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE:  We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.