A prominent pharmaceutical company, Bal Pharma Ltd, is currently seeking a highly experienced and dedicated professional to join its team. We are inviting applications for the position of Assistant Manager in Analytical Quality Assurance (AQA) at our Active Pharmaceutical Ingredient (API) facility located in Udaipur.
This crucial role demands a candidate with a substantial background, requiring a minimum of 10 years of experience specifically in API Pharma QA. Prospective candidates should hold a qualification of M.Sc, B.Pharm, or M.Pharm.
The chosen professional will be integral to managing and overseeing all Analytical Quality Assurance activities. This includes ensuring full compliance with current Good Manufacturing Practices (cGMP) and adherence to international ICH guidelines within the API manufacturing environment.
Key responsibilities for this role include:
* Reviewing and approving Analytical Method Validation (AMV), Limit of Detection (LOD)/Limit of Quantitation (LOQ), and System Suitability parameters (such as Symmetry and Resolution) as per USP standards.
* Managing various aspects of the Quality Management System (QMS), including handling deviations, incidents, Out-of-Specification (OOS)/Out-of-Trend (OOT) investigations (Phase I & II), change controls, and Corrective and Preventive Actions (CAPA).
* Conducting thorough reviews of stability studies, in line with ICH Q1 guidelines, and meticulously examining Raw Material (RM) and Finished Product (FP) specifications.
* Critically assessing analytical data generated from advanced instrumentation such as HPLC, GC, GCMS, XRD, and Residual Solvents analysis, adhering to ICH Q3C.
* Overseeing the review of Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), Specifications, Protocols, and Qualification documents.
* Providing essential support during Regulatory, Customer, and Internal Audits, while rigorously ensuring data integrity within the Quality Control Laboratory.
Candidates must possess comprehensive knowledge of ICH Guidelines, cGMP, Analytical QA methodologies, QMS operations, and demonstrate strong capabilities in audit handling, specifically related to ICH Q1 and Q3.
This is an outstanding opportunity for an accomplished AQA professional to make a significant impact within a dynamic and compliant pharmaceutical setting. Interested and qualified individuals are encouraged to submit their comprehensive resumes for consideration.
