Executive - Quality Assurance, Pharma at Zentiva

Ankleshwar, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Continuous Improvement, Line Clearance, Shop Floor Compliance, Complaint Investigation, Qualification and Validation, Change Control, Deviations, Annual Product Quality Review, Batch Manufacturing Records, cGMP Training, SOP Compliance, Corrective Actions, Preventive Actions, CAPA, Maintenance and Calibration

Industry

Pharmaceutical Manufacturing

Description

Job Description for Executive - Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in the Complaint Investigation system at site Assisting in the Qualification and validation system, change control system, deviations Preparing & reviewing the Annual Product Quality Review Review of Batch Manufacturing & Packing Records Coordination of cGMP Training activity. Compliance Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by Understanding the requirements Performing the Gap analysis to find out the gaps in the existing system Preparing a compliance plan for the closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications: Ensure validated status of all equipment, manufacturing processes, and cleaning processes Review of protocols for qualification and validation of facility/equipment/product/process Review of validation reports after execution of validation of facility /equipment/product / process Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of documents & record Control of master documents Assuring quality of products by : Ensuring SOP compliance Review of Batch Manufacturing & Packing Records Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints Ensuring the effectiveness review of the implemented CAPA cGMP Training: To prepare training modules and organize training in GMP Execute the training program in coordination with all concerned departments Other: Review of maintenance and calibration program Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4 700 people and a network of production sites - including flagship sites in Prague, Bucharest, and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better support people’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high-quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators, and governments to provide the everyday solutions that we all depend on.

Responsibilities

The Executive in Quality Assurance will ensure adherence to quality standards and compliance with local regulations. Responsibilities include assisting in complaint investigations, managing qualification and validation systems, and preparing compliance plans.