QA/QC Manager

Ashland India Private Ltd

JD: QA/QC Manager

Job Description

Are you the kind of person who 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/QC Manager to join our Operations Team at our Ambernath Plant, Mumbai. This is a very visible, significant role within the Company and the Quality division. This position will report to the Quality Director.
 

The QA/QC Manager will be responsible for establishing, implementing, and maintaining robust quality systems to ensure compliance with applicable regulatory standards such as FDA guidelines, ISO 9001, EXCiPACT and ICH requirements, as well as food safety requirements such as GFSI and FSSC/ISO 22000. The role covers both quality assurance (system-driven) and quality control (analytical/testing) functions for ready-mix Tablet Film coating products.

Key Responsibilities

1. Quality Assurance (QA)

• Develop, implement, and maintain Quality Management System (QMS).
• Ensure compliance with GMP, GLP, and regulatory requirements.
• Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Standard Operating Procedures (SOPs)
• Manage Change control, Deviations & investigations and CAPA (Corrective & Preventive Actions)
• Conduct internal audits and ensure audit readiness for regulatory inspections.
• Vendor qualification and raw material approval.

2. Quality Control (QC)

• Establish and manage QC laboratory operations.
• Approve specifications, test methods, and analytical protocols.
• Oversee testing of Raw material, in-process samples and Finished Products.
• Ensure calibration and maintenance of instruments (e.g., HPLC, UV, moisture analyzer).
• Review and approve COAs (Certificates of Analysis).

3. Regulatory & Compliance

• Ensure compliance with Maharashtra FDA requirements, Pharmacopeial standards (IP, USP, EP, ChP)
• Lead regulatory inspections and audits.
• Maintain documentation for licensing and product approvals.

4. Validation & Qualification

• Oversee: Cleaning Validation, Analytical Method validation.
• Ensure IQ/OQ/PQ execution for equipment and utilities.

5. Team Leadership

• Lead QA/QC team (chemists/ officers).
• Training and development of team members.
• Drive quality culture across manufacturing and support functions.

6. Documentation & Data Integrity

• Ensure compliance with data integrity principles (ALCOA+).
• Maintain proper documentation control systems.
• Ensure traceability and audit-ready records.

Key Qualifications

Education

• M.Pharm / B.Pharm / M.Sc./B.Sc. (Chemistry / Analytical Chemistry)

Experience

• 10–15 years in pharmaceutical / excipient manufacturing.
• Minimum 5 years in QA/QC leadership role.

Required Skills & Competencies

• Strong knowledge of GMP & regulatory frameworks and Excipient manufacturing processes
• Expertise in: QMS systems, Analytical techniques
• Leadership & team management
• Problem-solving and decision-making skills
• Audit leader (Regulatory & customer audits, internal audits)

Preferred Experience

• Experience in excipient or coating systems manufacturing
• Exposure to international regulatory audits
• Chemical and instrumentation competent staff approval
• Demonstrated success in continuous improvement

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.