This page was automatically translated and may contain errors. View in English.
L

Executive - Quality Assurance

Lupin

Pimpri-Chinchwad, Maharashtra, India · Tempo pieno

Sii il primo a candidarti

Esperienza
3–5 yrs
Stipendio
Aperture
1
Pubblicato
12 ore fa

Where you'll work

Descrizione del lavoro

Role OverviewThis position is for a Quality Assurance professional to support GMP compliance across manufacturing and warehouse operations in Pune/Pimpri-Chinchwad. The role focuses on documentation review, validation oversight, investigation support, and quality system upkeep in line with regulatory expectations and approved procedures.Key DutiesCarry out site visits to DS manufacturing and warehouse facilities to confirm that operations are aligned with GMP standards, regulatory needs, and approved procedures.Take part in manufacturing investigations and help close CAPA actions.Draft and review risk assessments along with mitigation plans.Monitor process validation and cleaning validation work to ensure execution matches approved protocols.Examine core master documents such as study protocols, BPRs, and MFRs.Check executed Batch Processing Records to support batch release decisions.Review Batch Dispatch Records and confirm warehouse dispatch activities.Coordinate the collection and compilation of APQR data and support preparation of the APQR.Prepare and review SOPs and other quality system documents.Review departmental SOPs to verify GMP compliance across functions.Experience RequiredThe role calls for 3 to 5 years of relevant experience.Education RequiredCandidates should have a Master’s degree in Biotechnology, or a postgraduate qualification in Pharmacy or Pharmaceutical Technology.CompetenciesInnovation and creative thinkingCustomer focusTalent development mindsetResults-driven approach

Competenze

Garanzia di qualità Valutazione del rischio Regulatory Compliance CAPA Management Good Manufacturing Practice (GMP) Validation Review Batch Record Review SOP Documentation APQR Preparation Pharmaceutical Quality Systems

Lasciate questo messaggio se desiderate una risposta: non lo useremo per nessun altro scopo.

Clicca per navigare, trascina e rilascia, oppure impasto uno screenshot

PNG, JPG, GIF, MP4, WebM, MOV · Dimensione massima 20 MB ciascuno · Fino a 5 file