Zentiva Pharma QA Executive Position Available! BPharma & MPharma Apply!
Executive I – QA, Pharma (IPQA)
Locations: India / Ankleshwar
Time Type: Full time
Posted On: Posted Yesterday
Time Left to Apply: End Date: November 30, 2024 (30+ days left to apply)
Job Requisition ID: R2467185
Generic
Implement Quality Assurance activities for Pharmaceutical at Ankleshwar, adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products that meet customers’ requirements, while upholding Group’s Values and Code of Ethics.
Specific Additions (if needed): Not Applicable
KEY ACCOUNTABILITIES
Quality Management/Continuous Improvement
- Line clearance and shop floor compliance
- In-process checks and sampling activity
- Assisting in complaint investigation system at the site
- Assisting in qualification and validation system, change control system, and deviations
- Preparing and reviewing the Annual Product Quality Review
- Reviewing Batch Manufacturing & Packing Records
- Coordinating cGMP training activities
Compliance
- Ensure adherence to company Quality Standards, Local FDA, and MHRA regulations by:
- Understanding requirements
- Performing gap analysis to identify gaps in the existing system
- Preparing a compliance plan to close gaps
- Executing compliance plans
- Reviewing completion of compliance activities
Validations & Qualifications
- Ensure validated status of all equipment, manufacturing processes, and cleaning processes
- Review protocols for qualification and validation of facility, equipment, product, and process
- Review validation reports post-execution for facility, equipment, product, and process
Documentation Control
- Preparation and review of SOPs
- Controlled distribution and archival of documents and records
- Control of master documents
Assuring Quality of Products by:
- Ensuring SOP compliance
- Reviewing Batch Manufacturing & Packing Records
- Ensuring implementation of corrective actions and preventive actions proposed in deviations and customer complaints
- Ensuring the effectiveness review of the implemented CAPA
cGMP Training
- Prepare training modules and organize GMP training
- Execute the training program in coordination with all concerned departments
Other Responsibilities
- Reviewing maintenance and calibration programs
- Identifying and correcting unsafe conditions or behaviors, and promptly reporting other potentially hazardous situations
Dimension
- (e.g., Budget, number of people managed)
REQUIREMENTS
Education / Experience
- Education: Graduate/Post Graduate in Pharmacy
- Experience: 1 – 3 years in the pharma industry with awareness of quality management systems, manufacturing activities, process validation, qualification, and regulatory requirements
Technical Skills & Competencies / Language
- Knowledge of GMP and regulatory requirements
- Good interpersonal skills and ability to manage conflicts
- Belief in and adherence to company values
- Teamwork skills
- Ability to present complicated technical issues in an understandable manner and prompt appropriate actions
Link to Original Notification to apply
Keywords: Job Posting, Executive I, QA, Pharma, IPQA, Zentiva, Ankleshwar, Pharmaceuticals, Quality Assurance, GMP, Regulatory Requirements, SOP. Zentiva Pharma QA Executive Position Available! BPharma & MPharma Apply! Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
