Quality assurance(IPQA) Associate

Avani Consulting; Nanjanagudu; On-site; INR 600,000 - 800,000; Full time

Job summary

Avani Consulting is seeking an Associate / Sr Associate - QA in the Mysuru area (Nanjangud). The role requires hands-on IPQA, GMP documentation, batch reviews, and QA release activities across manufacturing and packing operations.

Candidates with M.Sc. in Chemistry/Life Sciences or D.Pharm/B.Pharm/M.Pharm as well as SOPs, QMS, audits, deviations, CAPA and LMS portal handling will fit well. Join a team focused on cGMP compliance and quality systems.

Qualifications

• Hands-on IPQA and QA activities on GMP shop-floor.
• Experience in reviewing GMP docs, BMR/BPR and cleaning records.
• Exposure to SOPs, QMS documents, and audits.

Responsibilities

• 1. In-Process Quality Assurance (IPQA) activities, including shop-floor monitoring and routine QA rounds.
• 2. Review of GMP documentation and batch-related records.
• 3. Review and approval of Batch Cleaning Records (BCR) and Equipment Cleaning Records (ECR).
• 4. Cleaning Validation activities, including protocol execution and report review.
• 5. Line Clearance verification for manufacturing and packing operations.
• 6. Review of Process Batch Manufacturing Records (BMR) and Packing Batch Records (BPR).
• 7. QA release activities for finished products.
• 8. Equipment Qualification activities, including IQ, OQ, PQ review and approval.
• 9. Review, preparation, revision, and management of SOPs and other Quality Management System (QMS) documents.
• 10. Participation in and support for Internal Audits, self-inspections, and compliance initiatives.
• 11. Handling of deviations, change controls, CAPAs, and other quality systems will be an added advantage.
• 12. Experience in Learning Management System (LMS) administration and portal handling will be an added advantage.
• 13. Familiarity with regulatory requirements, data integrity practices, and cGMP compliance.

Skills

IPQA

GMP

QA documentation

Batch records review

Cleaning validation

Line clearance

BMR/BPR review

QMS SOPs

Internal audits

CAPA management

LMS administration

Regulatory data integrity

Education

M.Sc. (Chemistry/Life Sciences)

D.Pharm

B.Pharm

M.Pharm

Job description

Hii,

Greetings from Avani Consulting

We have job openings with a leading Pharma company mysore location.

Position : Associate / Sr Associate - QA

Location: Mysuru(Nanjangud)

Qualification: M.Sc. (Chemistry/Life Sciences) / D.Pharm / B.Pharm / M.Pharm

Key Responsibilities and Required Experience:

The candidate should possess hands-on experience in the following areas:

• 1. In-Process Quality Assurance (IPQA) activities, including shop-floor monitoring and routine QA rounds.
• 2. Review of GMP documentation and batch-related records.
• 3. Review and approval of Batch Cleaning Records (BCR) and Equipment Cleaning Records (ECR).
• 4. Cleaning Validation activities, including protocol execution and report review.
• 5. Line Clearance verification for manufacturing and packing operations.
• 6. Review of Process Batch Manufacturing Records (BMR) and Packing Batch Records (BPR).
• 7. QA release activities for finished products.
• 8. Equipment Qualification activities, including IQ, OQ, PQ review and approval.
• 9. Review, preparation, revision, and management of SOPs and other Quality Management System (QMS) documents.
• 10. Participation in and support for Internal Audits, self-inspections, and compliance initiatives.
• 11. Handling of deviations, change controls, CAPAs, and other quality systems will be an added advantage.
• 12. Experience in Learning Management System (LMS) administration and portal handling will be an added advantage.
• 13. Familiarity with regulatory requirements, data integrity practices, and cGMP compliance.