Documentation QA-Quality Assurance Quality Assurance
Key Responsibilities
Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management
Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.
Ensure accurate and timely completion of all quality-related documentation. Product Quality Control
Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs).
Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
Making decisions on batch disposition and product recall based on root cause identification.
Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance.
Preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed.
Timely completion of APQR related activity
Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,)
Handling of Market Complaint and Related Compliance
Handling of out of specification and suitable investigation
Handling of Deviation and Incident
Prepared BMR, SOP, Protocols etc.
Compliance of Vendor Audit, Regulatory Audit etc.
Skills & Qualification
Education:
UG: B.Sc / B.Pharm
PG: M.Sc / M. Pharm
Knowledge of computer competence, including database management
Minimum Experience Required: 1 - 3 Year
CV Required
Experience : 1 - 5 Years
No. of Openings : 1
Education : B.Pharma, B.Sc, M.Pharma, M.Sc
Role : Quality Assurance Executive
Industry Type : Manufacturing / Production / Quality
Gender : [ Male / Female ]
Job Country : India
Nexus Pharma chem Pvt. Ltd. Active Pharmaceutical Ingredients (APIs) manufacturing company based at Ahmadabad, Gujarat, is in the business of development, production and marketing of Corticosteroid APIs The company has been renovated and the new management has commenced operations from January 2019. The new technical and regulatory team with their focus on quality is geared up to meet all technical and regulatory challenges either for the domestic or international market.
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