Manager/Lead Associate, Quality Improvement
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
We have an opening for an Manager/Lead Associate, Quality Improvement in our Princeton, NJ office.
This role will be responsible for:
- Periodic generation and assessment of laboratory metrics and related data (invalid OOS, incidents, and key process like Samples flow, calibrations, stability, standards management) to identify and close gaps
- Supports and Identify key method issues to be resolved at each QC laboratory with potential to impacts commercial product supply and FDA filings.
- Conducts gap assessment on QC systems and provide inputs for updating the site QC procedure's in line with current regulatory expectations and DRL guidelines
- Performs and Supports timely and thorough writing and review of Investigations (Operations, deviations, OOS, OOT, Incidents) and escalates the critical events that impact product availability across the North America region internal and external sites
- Provides path forward and oversight on internal and external site investigations
- Initiate and support efforts to reduce validation of OOS rate and repeated personnel errors and identification of root causes
- Review of all analytical data generated per relevant SOPs. (Electronic data review, Raw data review Etc.)on need basis
- Reviews protocols, raw data and reports related to analytical development, Validation/verification and method transfer.
- Reviews and approves Product Development, New Product launches and Regulatory submissions Method Validation and Transfer, process validation protocols, reports and documents per DRL SOPs and regulations.
- Assist in Stability management rationalization, Stability Protocols review, Stability data review
- Track, coordinate and implement Pharmacopeia changes at sites across North America
- Support team for identifying the current trends in GMP/GLP and regulatory guidelines and assist in implementation by setting procedural controls
- Coordinating with site Quality team and assisting for simplification of stability/Release sample management.
- Assessment of DRL site procedures against DRL Global guidelines and Author/Update relevant SOPs
- Support the Audit team in scheduling and performing internal and external partner assessments.
- Performs/Support audits of DRL North America sites: Canada, Middleburgh, Princeton, Shreveport and CMO/CTL sites
- Supports to ensure that Quality Agreements with Contract Testing Laboratories and external partners are in place
Education & Experience:
- Bachelor’s Degree (or its U.S. equivalent) in Life Sciences, Pharmaceutical Sciences or a closely related field with 8+ years of experience in a pharmaceutical and/or biotech.
- Strong knowledge in In Pharmaceutical manufacturing and/or Laboratory techniques; especially Chromatography(HPLC, GC), Dissolution and compendia test procedures
- Experience in handling Analytical Method Validation, Method Transfer activities Experience in handling Laboratory and Operations investigations, Out of Specifications/Out of Trends and CAPAs
- Strong understanding of pharmaceutical process and/or method development and testing processes, and familiarity with Quality Management Systems.
- Familiarity with Data Integrity and Data review controls
- Thorough understanding of GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents
- Must have prior experience in working with cross-functional teams
- Excellent communication (verbal and written), strong analytical and investigative, organizational and time management skills; Strong attention to detail.
- Excellent negotiation and influencing skills required.
Equal Opportunity Employer: Minorities/Women/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.