QA Executive

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

Aspirants must send their resume to [email removed] or contact us at [phone removed] to discuss the opportunity.