Executive -Lab QA-Quality Assurance-Peptide API-Raks Pharma, Dahej

Raks Pharma Pvt Ltd (Dahej) A div. Amneal Pharmaceuticals; Dahej; On-site; INR 600,000 - 900,000; Full time

Job summary

Raks Pharma Pvt Ltd (Dahej) A div. Amneal Pharmaceuticals is seeking an API Quality Assurance professional to oversee QC/ADL documentation, investigations, and data integrity. The role emphasizes regulatory compliance and robust CAPA processes within a USFDA/EU-approved facility.

The candidate should have a strong background in stability studies, OOS/OOT investigations, and cross-functional coordination to ensure continuous improvement and compliance across all QC activities.

Qualifications

• MSc/ BPharm/ MPharm or equivalent required.
• 5–7 years of API QA experience in USFDA/EU-approved facility.

Responsibilities

• Review QC, stability/ADL documents.
• Participate in OOS/Deviation/Incidents/OOD in investigations/OOT/OOAL.
• Prepare and review trend analyses and stability reports.
• System administration with IT for QC/ADL instruments.
• Review analytical data via software and hard copy.
• Monitor calibration and preventive maintenance of QC/ADL instruments and equipment.
• Review/approve stability protocols and data (stability schedule/analyses).
• System monitoring of QC/ADL on daily basis.

Skills

cGMP knowledge

Regulatory compliance

Data integrity

OOS/OOT investigations

CAPA management

Documentation review

Education

M.Sc. / B.Pharm / M.Pharm or equivalent

Job description

Role & responsibilities

1.To review of QC, stability /ADL related documents.

2.To participate in OOS / Deviation / Out of calibration investigations / Incidents / OOT / OOAL.

3.To prepare and review Trend analysis, stability reports.

4.System Administration control along with IT for QC/ADL instrument and equipment.

5.To review analytical data through application software/ hard copy, randomly.

6.To monitor calibration and preventive maintenance of QC/ADL Instrument and equipment as per schedule.

7.To review /approve stability protocol/schedule /Analysis data/stability study report.

8.System monitoring of QC / ADL on daily basis.

Preferred candidate profile

• M.Sc.(Chemistry)/B. Pharma. / M.Pharm. or equivalent qualification.
• 0507 years of relevant experience in API Quality Assurance in a USFDA/EU-approved pharmaceutical manufacturing facility.

Key Competencies

• Strong knowledge of cGMP, regulatory compliance, QC/ADL oversight, data integrity (ALCOA+), analytical data and stability review, OOS/OOT/OOAL and deviation investigations, trend analysis, laboratory instrument and computerized system controls, risk assessment, CAPA management, and effective documentation review and cross-functional coordination.

• To maintain an effective and compliant API Quality Management System through proactive quality oversight, robust investigations, effective CAPA, controlled documentation, customer satisfaction, regulatory compliance, and continual improvement.