Role & responsibilities

- Qualification: B.Pharm, M.Pharm,
- Experience: 6 to 12+ years of Oral dosage (Tab, Capsule, Liquid, Softgel) QA/IPQA /QMS/ QA Trainer

experience, with exposure to nutraceutical industry.

IPQA In-charge

Key Responsibilities

- Shop-Floor Oversight: Supervise daily IPQA teams across shifts, monitoring Critical Process

Parameters and Critical Quality Attributes

- Line Clearance & Verification: Authorize line clearances for product/batch changeovers,

dispensing, granulation/manufacturing, compression, coating, and packaging.

- QMS Management: Handle deviations, Corrective and Preventive Actions , and change

controls.

- Audit Readiness: Act as a key quality representative during customer, internal, and regulatory inspections

Required Skills & Competencies

- Regulatory Knowledge: Deep understanding of FSSAI, WHO GMP, ICH guidelines, and

ALCOA++ data integrity principles.

- Technical Expertise: Experience with process/cleaning validation, APQR and calibration.
- Experience to Handle 20+ Peoples team.

QA/ QMS

Key Responsibilities

- QMS Governance: Manages core QMS elements including deviations, non-conformances,

Corrective and Preventive Actions , change controls, and market complaint investigations.

- Audit & Inspection Readiness: Prepares site operations for internal, customer, and global

regulatory inspections

- Defending Compliance: Hosts regulatory audits, drafts root-cause investigations (using





tools like 5-Why or Fishbone diagrams), writes audit observation responses, and fulfill

CAPA timelines.

- Self-Inspections & Vendor Audits: Conducts internal GMP self-inspections and performs

qualification/technical assessments

- Documentation & Data Integrity: Oversees Standard Operating Procedures , Batch

Manufacturing/Packaging Records , Annual Product Quality Reviews.

QA Trainer

Key Responsibilities

- Training Needs Identification: Conduct skill-gap analyses by comparing required

competencies against existing employee capabilities based on role changes, recent

equipment, and regulatory updates.

- Curriculum & Module Design: Develop induction programs, annual cGMP refreshers,

safety/hygiene modules, HACCP and crisis management protocols.

- On-the-Job Training : Oversee practical shop-floor training for equipment operation, batch

manufacturing record execution, and manufacturing processes.

- Documentation Governance: Manage Learning Management Systems , maintain individual

training files, update SOP matrices, and archive records for Customer regulatory audits

- Evaluation & Certification: Assess employee competency through written/oral exams,

practical demonstrations, and performance metrics, issuing trainer or operator

certifications.

Interested Candidates may#share CV On following Addresses :-

[email protected] & (phone hidden) (Whatsaap)

📌 QA - IPQA Incharge / QMS / QA Trainer (Pithampur)
🏢 Makin Laboratories
📍 Pithampur