Job Title: Executive I – Quality Control
Location: Ahmedabad, Gujarat
About Baxter:
Join a leading global healthcare company dedicated to innovations that save and sustain lives. At Baxter, we are committed to fostering a culture of trust, collaboration, and inclusion, where every employee can contribute to making a meaningful impact on patient care. If you are a detail-oriented professional with a passion for quality and regulatory compliance, we encourage you to apply for the Executive I – Quality Control position in Ahmedabad.
Job Summary:
Baxter is seeking a highly motivated and experienced Executive I – Quality Control to join our team in Ahmedabad. In this role, you will be responsible for managing quality documentation, ensuring regulatory compliance, and upholding cGMP standards within the Quality Control department. You will play a crucial role in maintaining the integrity of our quality systems and contributing to the overall success of our organization.
Responsibilities:
As an Executive I – Quality Control, your key responsibilities will include:
- Preparing Specifications, Standard Testing Procedures (STP), Certificates of Analysis (COA), calculation sheets, and analysis reports in accordance with reference Analytical Development Laboratory (ADL) documents.
- Updating addendum and specification indexes on a quarterly basis.
- Providing COA based on Quality Control requirements.
- Initiating Deviation Change Request (DCR)/Change Control Management (CCM) for updates in STP and calculation sheets.
- Ensuring that updated calculation sheets are readily available in the Controlled Form System (CFS).
- Initiating and closing Non-Conformance Reports (NCR), DCR, CCM, and Corrective and Preventive Action (CAPA) tasks within established timelines.
- Maintaining all documentation records in alignment with regulatory compliance requirements and current Good Manufacturing Practices (cGMP) standards.
- Preparing and updating departmental Standard Operating Procedures (SOPs).
- Reviewing, releasing, and setting effective document dates in TcU (or other document management system).
- Providing user training for TcU and linking new documents into the respective system.
- Maintaining document inventory and ensuring secure central record storage.
Qualifications:
To be successful in this role, you should possess the following qualifications:
- Bachelor’s or Master’s degree in Pharmacy or a related Life Science discipline.
- Proven experience in Quality Control documentation within the pharmaceutical industry (preferred).
- Comprehensive knowledge of cGMP, documentation systems, and regulatory compliance requirements.
- Experience with SOP writing, DCR, CCM, NCR, and CAPA handling processes.
- Strong organizational and communication skills, with the ability to effectively collaborate with cross-functional teams.
Why Join Baxter?
At Baxter, we offer a rewarding career experience that includes:
- Impactful Work: Contribute to a mission-driven organization dedicated to improving patient lives through innovative healthcare solutions.
- Supportive Culture: Thrive in a work environment that values trust, collaboration, accountability, and inclusion.
- Equal Opportunity: Baxter is an equal opportunity employer committed to fostering a diverse and inclusive workplace.
- Career Growth: Access opportunities for professional development and advancement within a global organization.
- Making a difference: Be part of a team dedicated to global healthcare accessibility.
We are looking for passionate individuals who are eager to make a difference and contribute to our mission of saving and sustaining lives. If you are seeking a challenging and rewarding career in Quality Control, we encourage you to apply.