Acme Generics Quality Assurance Officer

Acme Generics, based in Baddi, Himachal Pradesh, is a leading pharmaceutical company recognized for its commitment to quality, innovation, and excellence. With a robust presence in the generics market, Acme Generics consistently upholds its promise to deliver affordable and high-quality medicines. The company emphasizes compliance with regulatory standards, fostering a culture of continuous improvement and operational efficiency.

Job Responsibilities

As a Quality Assurance Officer/Executive at Acme Generics, you will play a crucial role in maintaining the company’s high-quality standards. Your key responsibilities include:

1. Documentation Control
   • Receiving, storing, controlling, issuing, retrieving, and destroying documents as a documentation controller.
   • Preparing and controlling master copies as per document control procedures.
   • Conducting periodic reviews to ensure all documents are updated and effective.
   • Issuing analytical worksheets, QMS documents, and monitoring online documentation across departments.
2. Validation and Reporting
   • Preparing and reviewing process validation protocols and reports.
   • Collecting data and preparing hold time study, stability compilation, cleaning validation, and packing validation reports.
3. Archival Management
   • Maintaining an easy-to-retrieve archival system for both soft and hard copies of documents.
4. Quality Management
   • Managing QMS documentation, including change control records.
   • Reviewing executed batch manufacturing and packing records.
   • Ensuring stability sample loading, pullout, and submission to QC.
5. Training and Trend Analysis
   • Participating in and coordinating training sessions.
   • Collecting and analyzing data for Annual Product Quality Review (APQR) trends.
6. In-Process Quality Assurance (IPQA)
   • Conducting IPQA activities to ensure adherence to quality standards.

Qualifications

To qualify for this role, candidates should have:

• A Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or a related field.
• Previous experience in quality assurance, particularly in a pharmaceutical manufacturing environment.
• Strong knowledge of documentation procedures, quality management systems, and validation processes.

Skills

The ideal candidate will possess:

• Excellent organizational and documentation skills.
• Proficiency in data analysis and report preparation.
• Strong communication and teamwork abilities.
• An eye for detail and a commitment to quality assurance standards.
• Familiarity with regulatory compliance and guidelines in the pharmaceutical industry.

Application Link