Are you looking to advance your career in the pharmaceutical industry? An exciting new opportunity is available at Ankleshwar, India for the position of Executive I – Quality Assurance (QA) with a full-time role. If you are a graduate or postgraduate in Pharmacy or Chemistry with a passion for quality management and pharmaceutical processes, this might be the perfect fit for you.
Key Accountabilities:
As an Executive I – QA, your responsibilities will revolve around ensuring the highest level of quality compliance in pharmaceutical manufacturing. Here’s a breakdown of the key tasks:
Quality Management / Continuous Improvement:
- Ensuring line clearance and shop floor compliance.
- Conducting in-process checks and sampling activities.
- Assisting with the Complaint Investigation System at the site.
- Supporting qualification, validation systems, and handling change controls and deviations.
- Preparing and reviewing the Annual Product Quality Review (APQR).
- Reviewing Batch Manufacturing and Packing Records.
- Coordinating cGMP training activities to ensure compliance with Good Manufacturing Practices.
Compliance:
- Ensuring adherence to company quality standards and regulatory requirements such as FDA MHRA regulations.
- Conducting gap analysis to identify gaps in the existing system and creating a plan to address them.
- Executing compliance plans and ensuring completion.
Validations & Qualifications:
- Reviewing the validated status of all equipment, processes, and cleaning methods.
- Reviewing qualification and validation protocols and validation reports to ensure the quality and efficiency of production processes.
Documentation Control:
- Preparing and reviewing Standard Operating Procedures (SOPs).
- Controlling the distribution and archiving of documents.
- Managing master documents and ensuring SOP compliance.
cGMP Training:
- Developing and executing GMP training programs in coordination with various departments.
- Preparing training modules to ensure employees stay updated on Good Manufacturing Practices.
Other Key Responsibilities:
- Assisting with the maintenance and calibration program.
- Identifying and reporting unsafe conditions, ensuring workplace safety.
Requirements:
Education:
- Graduate or Post Graduate in Pharmacy or Chemistry.
Experience:
- 0-3 years of experience in the pharmaceutical industry.
- Knowledge of Quality Management Systems, Process Validation, and Regulatory Requirements.
Skills & Competencies:
- Familiarity with GMP and regulatory guidelines.
- Strong interpersonal skills and the ability to resolve conflicts.
- Proficiency in teamwork and collaboration.
- Capable of presenting complex technical issues in a simplified manner.
How to Apply:
If you meet the qualifications and are interested in joining a dynamic pharmaceutical company, apply for the position by referring to the job requisition ID: R2466942.
