Head - Corporate Quality Control - Pharma

We are looking for a candidate for the position of Head - CQC (Corporate Quality Control) with an MNC Neutraceutical company based in Pune.

Job Description

Position:- Head - CQC (Corporate Quality Control)

Education/ Qualification: Ph.D/PG in Chemistry

- Experience of around 15 years in quality control in API/pharmaceutical Industry.

Location: Pune

CTC: 30 lakhs

Role:

- Built process & system & ensure adherence & compliance with cGMP & GLP Quality system and customer service across all sites & process lines including 3P.

- To ensure the adherence to Quality norms & systems w.r.t. Food Safety requirements, HACCP, SOPs, Specifications, Labeling requirements, Stability Study and Validation Data & Reports, new products documents etc. in order to comply with regulatory & statutory requirements.

- Ensure activities of Cleaning Method for multi product facility & Analytical Method Validation, effective transfer and stabilization of technology from R&D to plants for new products analytical process with respect to qualification and validation in coordination with Site QA.

- Ensure for the preparedness of systems/records for external inspections/audits from Regulatory agencies / Certifying Agencies or Customers for successful management of the Audit process at Labs of all operating sites.

- To evaluate the performance of vendor materials for support to SCM for Vendor Rating & Qualification.

- To ensure compliance with specifications for Flower to meal to Oleo to Finished Product for every stage, impurities viz. Pesticides, Aflotoxine, Dioxin, Microbial contamination, Lean & By product management etc.

- To train & develop team capability for operation & trouble shooting for HPLC, GC & GCHS, UV/Vis Spectrophotometer, FTIR, HPTLC and other advanced technologies/instrumental analysis to ensure on time accurate results are provided.

- To develop & monitor the sample management system for Control samples, Validation sample, Stability samples & Market/Customer samples.

- To coordinate with Head QA for generating required analytical data for completion of management action plan on complaints, non-conformances / deviations observed in laboratory / process by taking preventive measures to avoid further non-conformances and deviations; Reducing complaints, deviations / non-conformances in the laboratory.

- To make sure that the calibration of Instruments and AMCs of the Instruments are carried out in time in Lab & plant.

- To ensure stability studies are carried out as per requirement & protocol.

- To verify the analytical records of all manufacturing sites for accurate, timely analysis & compliance to specification (internal audit of analysis results) & IPQC checks.

- To build strong Quality focus across the organization by imparting training, conducting workshops & in-house initiatives.

- Responsible for transfer of knowledge, mentoring and capability building at the operating level.

- To develop & implement Lab Information Management System for control of data & details,

- Manage performance of all his direct reports and take appropriate steps to enhance performance levels by providing suitable development plans.

Interested candidates can email their resume on bijit.sinha@achprofessionals.com

Bijit