Executive / Sr. Executive - QC/QA in Pharma Formulation @ Una/Ghiloth

NA; Solan, Mehatpur; On-site; INR 700,000 - 900,000; Full time

Job summary

Quality Assurance in Himachal Pradesh seeks professionals for QA Validation in Pharma Formulation/OSD. Responsibilities include qualification, IQ/OQ/PQ, and validation activities for tablet/capsule manufacturing.

Candidates should have 1–7 years of QA Validation experience, preferably in pharma formulations, with strong process/cleaning validation knowledge and exposure to USFDA/WHO/EU GMP/MHRA. B.Pharm/M.Pharm preferred.

Qualifications

• 1-7 years of QA Validation experience in Pharma Formulation / OSD.
• Hands-on validation experience in Tablet/Capsule manufacturing preferred.
• Strong knowledge of Process Validation, Cleaning Validation & IQ/OQ/PQ.
• Exposure to USFDA/WHO/EU GMP/MHRA is advantageous.

Responsibilities

• Handle Equipment Qualification (DQ/IQ/OQ/PQ) and validation activities.
• Execute Process Validation & Cleaning Validation for tablet/capsule manufacturing.
• Prepare/review validation protocols, reports and risk assessments.
• Coordinate with Production, QC, Engineering and vendors for validation activities.
• Handle validation-related Deviation, CAPA and Change Control.
• Support HVAC, utility and facility qualification activities.
• Ensure compliance with cGMP and regulatory requirements.
• Support internal, customer and regulatory audits/inspections.

Skills

Equipment Qualification

Process Validation

Cleaning Validation

IQ/OQ/PQ

CAPA handling

Education

B.Pharm / M.Pharm

Job description

Job Responsibilities:

Key work Area: QA Validation Formulation / OSD

Location: Himachal Pradesh
Department: Quality Assurance
Dosage Forms: Tablets & Capsules

Location: Mehatpur(HP)/ Ghiloth(Rj)

Major KRAs;

• Handle Equipment Qualification (DQ/IQ/OQ/PQ) and validation activities.
• Execute Process Validation & Cleaning Validation for tablet/capsule manufacturing.
• Prepare/review validation protocols, reports and risk assessments.
• Coordinate with Production, QC, Engineering and vendors for validation activities.
• Handle validation-related Deviation, CAPA and Change Control.
• Support HVAC, utility and facility qualification activities.
• Ensure compliance with cGMP and regulatory requirements.
• Support internal, customer and regulatory audits/inspections.

Candidate Profile

• B.Pharm / M.Pharm preferred.
• 1-7 years of experience in QA Validation in Pharma Formulation / OSD.
• Hands-on experience in Tablet/Capsule manufacturing validation preferred.
• Strong knowledge of Process Validation, Cleaning Validation & IQ/OQ/PQ.
• Exposure to USFDA/WHO/EU GMP/MHRA will be an added advantage.

Preferred: Candidates currently working in OSD/Formulation plants with hands-on validation experience.