Manager-Development Quality Assurance

Role & responsibilities

* Prepare and Review SOPs and Guideline for DQA.

* Formulate Documentation Process for the Key divisions of SRD

and ARD.

* Review documents with respect to drug substance such as

protocols, SOPs, test methods, data COAs and report through

collaborate with CRD, ARD, and QC scientists.

* Successfully manage and complete all Audits that come up from

time to time and conduct periodic internal audits and ensure

compliance as per regulatory requirements

* Review process development documents including KSM/KRM

identification, specification proposal, analytical method

development and validation reports, stability protocols& reports

and safety studies.

* Handle Vendor Qualifications for KSM/KRM, Solvents etc.

* Ensure Regulatory compliance as per USFDA and other such

regulatory bodies.

* Impart training to all employees on SOPs/Safety. Support on

Onboarding on new employees joining the organization

* Responsible for assessing the impact, review and closure of

change control requests and deviations.

* Responsible for CAPA implementations, verifications of and

effectiveness.

Preferred candidate profile

* Mainly Preferred API Synthesis R&D Experience not formulation & Analytical

• Bachelors or Masters degree in Pharmaceutical Sciences,

Chemistry, Chemical Engineering, or related field.

• Minimum 5-8 years of experience in Quality Assurance, with

at least 3 years in a managerial or leadership role in the

pharmaceutical industry, specifically with API products.

• In-depth knowledge of GMP, ICH guidelines, FDA, EMA

regulations, and quality systems.

• Proven experience in conducting internal and external

audits, and leading regulatory inspections.

• Strong understanding of the API development and

manufacturing process.

• Ability to manage cross-functional teams and interact with

senior management.

• Experience in CAPA, deviation investigations, root cause

analysis, and risk management.