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Resonant Pharmaceuticals
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Quality Assurance Officer

Quality Assurance Officer

Resonant Pharmaceuticals

3 - 7 years

0 Lacs

gujarat

Posted:1 day ago| Platform: Shine logo

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Skills Required

standard operating procedures specifications vendor audit corrective preventive action capa protocol review sampling aql process validation cleaning validation master production control record batch packing records testing procedures outofspecification oos investigation complaint investigation external testing laboratories audit deviation review change control review non conformance review incidence review returned goods review destruction review annual product quality review apqr user requirement specifications review qualifications review validations review risk assessment review retention of records equipment list review drawings review preventive maintenance review calibration schedule review manufacturing activities clea

Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also review deviations, change controls, non-conformances, incidences, returned goods, and CAPAs. Your role will involve overseeing the destruction of starting materials, in-process materials, packaging materials, and finished products, as well as conducting the Annual Product Quality Review (APQR) and preparing associated reports. You will participate in the review of protocols and reports for user requirement specifications, qualifications, validations, Risk Assessment, and other studies at the site. Furthermore, you will be responsible for ensuring the retention and maintenance of records, reviewing equipment lists, drawings, preventive maintenance, and calibration schedules. You will provide clearance for various manufacturing and packing activities during day-to-day operations, conduct timely sampling/Acceptable Quality Level (AQL) checks at different stages, and perform sampling during process validation, Hold time studies, and cleaning validation. In-process checks will be conducted, and relevant records will be maintained on the shop floor. This is a full-time position with benefits such as Provident Fund, day shift or rotational shift schedules, performance bonuses, yearly bonuses, and the work location is on-site.,

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Quality Assurance Officer