Job summary
Job post source
This job is directly from Cipla USA
Job overview
The QA QMS Lead - Investigations at Cipla USA leads investigation teams to manage quality issues and ensure compliance in pharmaceutical manufacturing, impacting product quality and regulatory adherence.
Responsibilities and impact
The role involves leading investigations into OOS, OOT, deviations, complaints, preparing reports, collaborating across departments, implementing CAPA, overseeing process changes, conducting risk assessments, maintaining QMS documentation, training team members, and using QMS software like TrackWise and SAP.
Compensation and benefits
The position offers a competitive salary with a comprehensive benefits package including 401(k) matching, health insurance, HSA, FSA, PTO, paid holidays, disability coverage, parental leave, employee discounts, and potential bonuses based on performance.
Experience and skills
Requires a bachelor's degree in Science, Pharmacy, or related field with 5-8 years in pharmaceutical QA/QMS roles, strong cGMP knowledge, root cause analysis, CAPA management, proficiency in QMS software, technical writing, and regulatory guideline familiarity.
Work environment and culture
Cipla values diversity, equal opportunity, and inclusivity, supporting applicants with accommodations and fostering a collaborative, cross-functional team environment.
Company information
Cipla is a global pharmaceutical leader with over 85 years of history, known for affordable, high-quality medicines, with a strong presence in India, the U.S., and other markets; InvaGen Pharmaceuticals is its U.S. subsidiary focused on generic medicines.
Team overview
The candidate will join the investigation team at InvaGen Pharmaceuticals, working closely with QA, AQA, operations, and quality control departments in a collaborative setting.
Job location and travel
The job is located in Central Islip, NY, with standard work hours from 8:30 AM to 5:00 PM, and is for local applicants within Cipla's U.S. subsidiaries.
Unique job features
The role uniquely combines leadership in quality investigations with hands-on use of advanced QMS software and cross-departmental collaboration in a pharmaceutical manufacturing environment.
Company overview
Cipla USA is a subsidiary of Cipla Limited, a global pharmaceutical company headquartered in India. Specializing in the development, manufacturing, and commercialization of generic and branded pharmaceuticals, Cipla USA focuses on respiratory, oncology, and anti-retroviral therapies. The company generates revenue through the sale of its diverse product portfolio, which includes prescription medications, over-the-counter products, and active pharmaceutical ingredients (APIs). Founded in 1935, Cipla has a rich history of innovation and commitment to affordable healthcare, playing a significant role in the global fight against HIV/AIDS by making antiretroviral drugs accessible.
How to land this job
Position your resume to highlight your leadership in leading investigation teams, especially in conducting thorough investigations of OOS, OOT, deviations, complaints, and non-conformances, as this is central to the QA QMS Lead role at Cipla USA.
Emphasize your expertise in root cause analysis, CAPA management, and proficiency with QMS software like TrackWise and SAP, along with your knowledge of cGMP, regulatory guidelines, and quality systems development.
Apply through multiple channels including Cipla USA's corporate career site, LinkedIn job postings, and other reputable pharmaceutical job boards to maximize your application visibility.
Connect with professionals in Cipla USA's quality assurance or regulatory affairs divisions on LinkedIn; use ice breakers such as commenting on Cipla's recent expansions in the US market or asking about their approach to quality system improvements and investigations.
Optimize your resume for ATS by incorporating keywords from the job description such as 'root cause analysis,' 'CAPA,' 'QMS software,' 'cGMP,' 'investigations,' and 'quality systems' to increase the chances of passing initial screenings.
Use Jennie Johnson's Power Apply feature to automate application submissions across multiple platforms, tailor your resume to the job, and identify relevant Cipla USA contacts for networking, allowing you to focus your time on preparing for interviews and skill development.
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