Quality Assurance Associate

2 - 6 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be mainly responsible for the documentation activities at the Par formulation Indore sterile facility. Your tasks will include managing documentation, training, and different software such as Doc pro, Veeva, and Compliance wire (LMS). Key Responsibilities: - Issuance of Record of Analysis - Issuance of controlled copies & uncontrolled copies of the standard operating procedure - Issuance of protocols, reports, layout, and forms - Issuance of logbook and drawing - Following cGMP Practices as per the defined procedure - Performing Distribution, retrieval, and destruction of documents as per defined procedure - Maintaining employee training files - Ensuring document controls at the site (Master production records/packaging records/Analytical documents, etc.) - Managing master and controlled documents in Documentation Cell - Alloting document number and equipment number as per the defined procedure - Stamping the controlled and uncontrolled copy and entry in the respective formats - Initiating change control related to doc cell activity - Generating Daily QMS data sheet as required and tracking pending tasks of documentation Qualifications Required: - Relevant experience in documentation management - Familiarity with software such as Doc pro, Veeva, and Compliance wire (LMS) - Knowledge of cGMP Practices - Strong attention to detail and organizational skills - Ability to follow defined procedures accurately Please Note: No additional details about the company were provided in the job description. Role Overview: You will be mainly responsible for the documentation activities at the Par formulation Indore sterile facility. Your tasks will include managing documentation, training, and different software such as Doc pro, Veeva, and Compliance wire (LMS). Key Responsibilities: - Issuance of Record of Analysis - Issuance of controlled copies & uncontrolled copies of the standard operating procedure - Issuance of protocols, reports, layout, and forms - Issuance of logbook and drawing - Following cGMP Practices as per the defined procedure - Performing Distribution, retrieval, and destruction of documents as per defined procedure - Maintaining employee training files - Ensuring document controls at the site (Master production records/packaging records/Analytical documents, etc.) - Managing master and controlled documents in Documentation Cell - Alloting document number and equipment number as per the defined procedure - Stamping the controlled and uncontrolled copy and entry in the respective formats - Initiating change control related to doc cell activity - Generating Daily QMS data sheet as required and tracking pending tasks of documentation Qualifications Required: - Relevant experience in documentation management - Familiarity with software such as Doc pro, Veeva, and Compliance wire (LMS) - Knowledge of cGMP Practices - Strong attention to detail and organizational skills - Ability to follow defined procedures accurately Please Note: No additional details about the company were provided in the job description.

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