QA Officer

**Review of Manufacturing Processes**: The QA person ensures that manufacturing processes meet the required quality standards by reviewing the manufacturing procedures, batch records, and testing protocols.
- **Product Release**: A QA person ensures that products are released only after they have met the required specifications and are deemed safe and effective.
- **Quality Control**: A QA person collaborates with the **Quality Control**(QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.
- **Audit**: The QA person 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.
- **Documentation**: A QA person is responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements.
- **Deviation Management**: The QA person is responsible for reviewing and approving deviation reports and ensuring that **corrective and preventive actions** (CAPA) are implemented.
- **Complaint Handling**: The QA person is responsible for reviewing and investigating product complaints to ensure implementation of **corrective and preventive actions** (CAPA).
- **Product recall**: The QA person 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).
- **Training**: A QA person is responsible for training of manufacturing and laboratory personnel on quality-related procedures and regulations.

**Apart from the above the QA person in a pharmaceutical industry should also perform the following duties and responsibilities**:

- **Quality management system**: Handling of quality management system (Change Control system, Deviation, Incident & other related documents).
- **Laboratory incidents**: Handling of out of specification (OOS) and out of trend (OOT) laboratory incidents and their closing.
- **Quality control**:Preparation & review the method of analysis (MOA), standard testing procedure (STP) and other documents related to QC.
- **Non-conformity**: Handling of non-conformity as per defined procedure.
- **SOPs**: Preparation & implementation of SOPs related to the concerned department.
- **BPR**: Implementation & verification, in-process checks, online entries in BPR of product at manufacturing site.
- **GMP**: Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.
- **GLP**: Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure.
- **Quality Risk Assessment**: Preparation & review of Quality Risk Assessment.
- **Line clearance**: To give line clearance before starting the new batch in production.
- **Sampling**: Sampling the intermediate, semi-finish & finish of product.
- **Raw material**: To verify dispensing of raw material.
- **Temperature & humidity**:Monitoring the record of Temperature & Relative Humidity in respective areas.
- **Product specifications**:Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
- **Standard for products**:Identifies and sets appropriate quality standards and parameters for products.
- **New technologies**: Evaluate new technologies and methods to make recommendations regarding their use.
- **Other documentation**:To prepare the Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, Plant Layout and other documents related to QA.
- **Customer**: To execute and providing the Documents to Customers.

Pay: ₹300,000.00 - ₹400,000.00 per year

Schedule:

- Rotational shift

Work Location: In person

**Speak with the employer**
+91 7807888715