Hemmo Pharmaceuticals Pvt. Ltd – Urgent Openings for Officer / Executive / Sr. Executive – Quality Assurance
Officer / Executive Quality Assurance
Preparing and reviewing Site Master File, Validation master plan, Master Batch Records.
Preparing and reviewing cleaning validation, process validation and Hold time study protocols and reports.
Reviewing of Batch Manufacturing Records, Batch Packing Records and Bill of material
Ensuring adherence to quality standards & maintaining all the related documents; conducting inspections at various stages to ensure safety & quality specifications are met without any slippages.
Steering the implementation of cGMP for all operational activities.
Conducting audits and ensuring compliance and audit readiness; reviewing production documents.
Participating in Internal Audits to ensure quality in other departments like Production, Stores, Engineering etc.
Addressing market complaints, deviation, CAPA, and change management systems.
Preparing and reviewing of Annual product Quality Review.
Imparting training, conducting online on job as well as classroom trainings for cGMP, cGDP to support subordinates
Preparing and reviewing SOPs related to Quality Assurance, Production, Stores and Engineering
Required Candidate profile:
Minimum 4 to 6 years of hands on experience in Quality Assurance and handling QMS system and Risk analysis
Executive QA / Sr. Executive QA
Establishing and ensuring the compliance of all systems as per GMP.
Handling of Customer complaints.
Conducting self-inspection and internal audit.
Facing Customer and Regulatory agencies audits
Ensuring proper responses to the customer or regulatory agencies including making report for audit compliance.
Taking plant rounds daily to ensure the compliance as per GMP.
Sound knowledge of evaluation of Risk analysis as per ICH Q 9 and implementation of CAPA.
Sound knowledge of elemental impurities analysis as per ICH Q 3D and USP
Performing risk analysis as part of Corrective and Preventive action for OOS / Change control and Deviations
10.Sound knowledge of Implementation Change control Deviation, OOS and generating risk analysis wherever required and closure of the same.
Required Candidate profile:
Minimum 7 to 9 years of hands on experience in Quality Assurance and handling QMS system and Risk analysis, Audit and Compliance.
Experience having worked in API plant with regulatory approval from USFDA, MHRA, EDQM.
Shall have good knowledge and requirement QMS, and ICH Q 9.
Skills / Knowledge/Abilities:
Strong technical background and knowledge of Quality management Systems.
Good oral and written communication skills.
Good knowledge of Microsoft office programs.
Ability to adapt and learn to ensure good decision making in fast pace environment.
Location: Navi Mumbai
Resume shall include following details:
Interested Candidates can send CV to email@example.com