Job Summary:
* Position: Quality Assurance (QA) Officer – Pharma API
* Location: Vapi
* Experience Required: 2 to 3 years in the pharmaceutical sector
* Qualification: B.Sc, M.Sc, B.Pharm, or M.Pharm
* Industry: Pharmaceutical Manufacturing (API)
* Compensation: Competitive salary commensurate with experience and interview performance
About the Company
Amgis Lifescience Ltd. is a rapidly growing player in the pharmaceutical industry, committed to excellence in manufacturing and quality standards. We pride ourselves on creating a professional, dynamic environment where dedicated individuals can grow their careers while contributing to the production of high-quality pharmaceutical products. We are currently expanding our operations in Vapi and are seeking a meticulous and skilled Quality Assurance Officer to join our team and uphold our commitment to quality.
Role Overview
As a QA Officer specializing in Active Pharmaceutical Ingredients (API), you will play a critical role in ensuring that our manufacturing processes consistently meet regulatory standards and internal quality benchmarks. The ideal candidate will possess a strong understanding of quality systems, documentation, and compliance within an API manufacturing environment. You will work closely with cross-functional teams to monitor production standards, manage quality documentation, and ensure that every stage of the lifecycle aligns with current Good Manufacturing Practices (cGMP).
Key Responsibilities
The successful candidate will be responsible for maintaining the highest levels of quality control and assurance. Primary duties include:
* Oversight of Manufacturing Processes: Monitoring API production activities to ensure adherence to established Standard Operating Procedures (SOPs) and cGMP guidelines.
* Documentation Management: Preparing, reviewing, and maintaining essential quality documentation, including batch production records, analytical reports, and investigation summaries.
* Compliance and Auditing: Participating in internal audits and supporting the preparation of documentation required for regulatory inspections.
* Quality Investigations: Assisting in the identification and documentation of any deviations or non-conformances, and participating in root cause analysis to implement effective corrective and preventive actions (CAPA).
* Training and Development: Ensuring that production staff remain updated on quality protocols and safety standards through periodic guidance and training sessions.
* Collaboration: Working in synergy with Production, Regulatory Affairs, and Warehouse departments to streamline workflows and ensure a seamless flow of operations.
Qualifications and Skills
To be considered for this position, candidates must meet the following educational and professional requirements:
* Education: Candidates must hold a degree in B.Sc, M.Sc, B.Pharm, or M.Pharm. A strong academic background in chemistry or pharmaceutical sciences is preferred.
* Experience: A minimum of 2 to 3 years of hands-on experience in a Quality Assurance role within an API (Active Pharmaceutical Ingredient) manufacturing facility.
* Knowledge: In-depth understanding of cGMP regulations, pharmaceutical quality systems, and regulatory requirements.
* Analytical Skills: Excellent attention to detail, strong problem-solving capabilities, and the ability to interpret complex technical data.
* Professional Attributes: The ability to work under minimal supervision, excellent communication skills, and a proactive approach to maintaining quality standards in a fast-paced environment.
Why Join Amgis Lifescience?
Joining Amgis Lifescience Ltd. offers you the chance to work in an environment that values professional development and technical excellence. As we continue to expand, we offer our employees clear pathways for career progression and the opportunity to make a tangible impact on the healthcare industry. We provide a competitive compensation package that reflects your skills, experience, and performance during the interview process.
Application Process
If you are a dedicated professional looking to advance your career in the pharmaceutical sector, we invite you to apply for this position. We encourage interested candidates to submit their updated resumes to our HR department for consideration.
To apply, please email your resume to [email protected].
For any specific inquiries regarding the application process or to follow up on your submission, you may contact us via phone or WhatsApp at 8141104608.
We appreciate all applications; however, only those selected for an interview will be contacted. We look forward to hearing from you and potentially welcoming you to the Amgis Lifescience team. If you know someone within your professional network who possesses the required skills and is looking for a new challenge, please feel free to share this opportunity with them.