Job Description

Ashland India Private Ltd

JD: QA/QC Manager

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