CGMP Jobs

Prepare, review, and maintain SOPs (Standard Operating Procedures), validation protocols, batch records, and other quality documents.Ensure compliance with cGMP, FDA, MHRA, WHO, and other regulatory guidelines.Conduct document control activities, including version control, issuance, retrieval, and archiving.Support internal and external audits by providing required documentation.Assist in equipment qualification (IQ, OQ, PQ) and validation processes.Coordinate with the QA/QC team to implement corrective and preventive actions (CAPA).Maintain training records for personnel involved in quality and compliance functions.Monitor and update quality documentation systems to enhance efficiency.

QA Manager / Asst QA Manager Responsibilities:-To handle calibration & validation activities at site.Preparation & review of Technical Documents like Site Master File, Validation Master Plan, Qualifications & Validation Protocols, Validation Reports, Master Formulas, Batch Manufacturing & Packing Records, Policies, Manuals Work Instructions, general and standard specifications and testing procedures & Standard Operating Procedures.To prepare, review & report annual product reviews & product stability reports.To investigate complaints, deviations, quality incidents and non-conformances and ensure implementation of CAPA.To control IPQC activities in production and packing of finished products.To handled external audits like regulatory audits and vendor audits.To indent QA requirements.To approve (sanction) leaves of QA department personnel..To conduct internal audits as per current Good Manufacturing Practices (cGMP) requirements.To issue Corrective Action & Preventive Action and to do follow up for effective implementation of Corrective Action & Preventive Action.To review and approve out of specification, quality incident, deviation, change control, validation documents.To Review and Release manufactured batch.Revision of SOPs & it's integration with Corporate Documents.Act as the pollution prevention, waste minimization and energy team member where applicable.Implementation of Quality Management System & Environment Management System requirements as applicable to IPQC function.To conduct training on Good Manufacturing Practices/Good Laboratory Practices in coordination with Human Resources department.Vendor development, evaluation & assessment of suppliers through auditsTo review Batch Manufacturing Records.To perform gap & risk analysis.To handle change controls.

The QC manager must have a minimum of 12 years of experience in a pharma QC lab.He/she must have hands-on experience in operation of HPLC, GC, IR, UV and other instruments used in pharmaceutical analysisResponsible for managing the QC laboratory in accordance with cGMPand GLP requirements. The Manager must be able to manage and lead a team of QC analysts in order to maintain smooth running of the laboratory. He will have to supervise regular testing on the incoming raw material, bulk and semi-finished product and finished product.Maintain regularity of testing and timely release of test reports.

Plan and manage all activities of Laboratory (analysis, chemical management, calibrations, standards management, investigations, incidents or out of specifications, method optimizations, validations .Manpower Planning ,Preferred candidate profile Having 2 to 3 Years of experience as a manager(Only Male).

High-performing professional with a reputation of successfully carrying out Project Design, execution & Management responsibilities.Demonstrated experience in developing Conceptual designs and carry out basic engineering and coordinate with detail engineering.Knowledge of cGMP norms, CCOE & OISD norms, Factory Inspectorate RuleShall have very good knowledge of FDA guidelines.Experience of Participation in HAZOP StudyLeading Project Team & Man Power Planning for effective utilisationLeading Meeting with Client, Contractors & VendorsTravelling to site during execution work for design coordinationSetting up Project Execution Plans & GuidelinesCoordination with Site Construction team

Post :- Quality Assurance OfficerIndustry :- PharmaLocation :- Vapi, GujaratQualification:- M.Sc, B.Pharma, M.Pharma Salary Range:- Upto 30K CTCExperience:- 4 to 5 YearsJob Responsibilities:1. To prepare new SOPs update the existing SOP as per requirements of cGMP.2. Preparation of Process & Cleaning validation and Equipment qualification protocol and report.3. To issue and review the deviation, change control, incident for impact on product quality and safety. Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessmentApply/Refer/Share

Tablets, capsules, ointments, oral liquids, dry powder injections and cosmetics. Manufacturing Exp.