QA Executive

Vlado Sky Enterprise; Indore District; On-site; INR 360,000 - 600,000; Full time

Job summary

Vlado Sky Enterprise in Indore is seeking a QA Executive to ensure pharmaceutical quality and regulatory compliance across manufacturing, testing, and distribution.

The role involves reviewing procedures, batch records, deviations, CAPA, audits, and document control, with a focus on GMP and GLP. Ideal candidates bring 2–5 years in pharma QA and strong analytical skills.

Qualifications

• 2–5 years of QA experience in pharmaceutical manufacturing.
• Familiar with GMP/GLP and regulatory requirements.
• Experience with quality systems and CAPA.
• Strong analytical and problem-solving abilities.

Responsibilities

• Review manufacturing procedures, batch records and testing protocols.
• Release products only after meeting specifications and safety.
• Maintain data integrity across data lifecycle.
• Collaborate with QC to ensure laboratory testing meets specs.
• Conduct internal audits to ensure GMP; assist with external audits.
• Ensure documentation is completed accurately and timely in regulatory compliance.
• Review deviation reports and ensure CAPA implementation.
• Investigate product complaints and implement CAPA.
• Investigate product recalls and perform root cause analysis and CAPA.
• Train personnel on quality procedures and regulations.
• Handle OOS/OOT incidents and closing.
• Prepare and review MOA, STP and QC documents.
• Handle non-conformity per defined procedures.
• Prepare and implement SOPs for the department.
• Implement and verify in-process checks and BMR/BPR entries.
• Monitor GMP at manufacturing site.
• Monitor GLP by lab personnel during analyses and instrument operation.
• Prepare and review Quality Risk Assessments.
• Provide line clearance before starting a new batch.
• Sample intermediate, semi-finish & finish products.
• QA executive verify dispensing of raw material.
• Monitor Temperature & Relative Humidity records.
• Develop and manage processes to meet required specs for quality and reliability.
• Identify and set quality standards and parameters.
• Prepare Annual Product Quality Review and QA documentation.
• Execute and provide documents to customers.

Skills

Wet chemistry

Sampling techniques

Analytical skills

Problem solving

Tools

HPLC

UV Spectroscopy

Polarimeter

Melting point apparatus

Vacuum oven

Muffle furnace

Flame photometer

Dissolution apparatus

Disintegration test

Friability tester

Job description

QA Executive

The primary role of Quality Assurance (QA) in pharmaceuticals is to ensure compliance with regulatory standards and uphold the highest levels of product quality, safety, and efficacy throughout all stages of manufacturing, testing, and distribution.

Job Responsibilities:

• QA executive ensures that manufacturing processes meet the required quality standards by reviewing the manufacturing procedures, batch records, and testing protocols.
• QA executive ensures that products are released only after they have met the required specifications and are deemed safe and effective.
• Maintaining data integrity by ensuring data is accurate, complete, consistent, and reliable throughout its lifecycle.
• QA executive collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.
• QA executive conducts regular internal audits of the manufacturing facility to ensure that the facility meets the required quality standards. Also handles the external audit cand its compliance.
• QA executive is responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements.
• QA executive is responsible for reviewing and approving deviation reports and ensuring that corrective and preventive actions (CAPA) are implemented.
• QA executive is responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA).
• QA executive is responsible for reviewing and investigating product which are called back due to some defects in the products and ensure implementation of root cause analysis (RCA) and corrective and preventive actions (CAPA).
• QA executive is responsible for training of manufacturing and laboratory personnel on quality-related procedures and regulations.
• To handling of out of specification (OOS) and out of trend (OOT) laboratory incidents and their closing.
• To Prepare & review the method of analysis (MOA), standard testing procedure (STP) and other documents related to QC.
• To handling of non-conformity as per defined procedure.
• To Preparation & implementation of SOPs related to the concerned department.
• To Implementation & verification, in-process checks, online entries in BMR/BPR of product at manufacturing site.
• To Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.
• To Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure.
• To Prepare & review of Quality Risk Assessment.
• To give line clearance before starting the new batch in production.
• Sampling the intermediate, semi-finish & finish of product.
• QA executive verify dispensing of raw material.
• To monitoring the record of Temperature & Relative Humidity in respective areas.
• To develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
• To identifies and sets appropriate quality standards and parameters for products.
• To prepare the Annual Product Quality Review, Plant Layout and other documents related to QA.
• To execute and providing the Documents to Customers.

Required Skills:

• Familiar with Wet Chemistry Techniques including pH testing, and Sampling Techniques
• Practical experience of Analytical Instrumentation such as HPLC, UV Spectroscopy, Polari meter, Melting Point Apparatus, Vacuum Oven, Muffle Furnace, Flame Photometer, Dissolution apparatus, Disintegration test apparatus, Friability etc.
• Strong analytical and problem-solving skills.

Experience Required:

2-5 yrs.

Job Location:

Indore