Quality Assurance Associate Manager

Skill required: Quality Governance & Operations - Operational Audit & Compliance

Designation: Quality Assurance Associate Manager

Qualifications:BSc/Bachelor of Pharmacy/Bachelor Degree in Life Sciences

Years of Experience:12 to 14 years

What would you do

You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world¢-

s leading biopharma companies bring their vision to life ¢-- enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
Quality Governance & Operations involves establishing and maintaining standards and processes to ensure the quality of products or services. This includes setting quality policies, conducting audits, and monitoring compliance with regulations. The goal is to create a consistent and reliable framework for quality management. Effective quality governance helps in minimizing risks, improving performance, and ensuring customer satisfaction. It is essential for maintaining the integrity and reputation of an organization.
Audit and manage effective implementation and delivery of functional processes within operations to mitigate risk. e.g. Policies; Anticorruption, BCM, InfoSec, P104, Records Management and Contractor controls. Establish processes to audit/validate current control effectiveness and drive improvements wherever required.

What are we looking for

Support as an SME for Clinical Quality Assurance

Roles and Responsibilities:

Review compliance to project specific requirements for maintaining records/documents, viz., hard copy and/or soft copy of onboarding, off boarding, training records, Organogram, Members List, Project access control records, JD, CV, HOTO forms, list of essential documents, minutes of meetings, governance decks, audit CAPA and its evidences, Pharma IT Controls list, CSV compliance of all tools, list of SOP/SWI, controlled copies of project specific SWIs etc.

Perform process risk assessments of the assigned projects as needed. Identify actions and track them to closure.

Perform process level checks using approved checklists and submit all reports on time.

Conduct relevant training for new hires / any revised courses / awareness trainings as applicable

Provide monthly inputs for inspection readiness in IR tool. Track and update status of IR action items.

Provide support during audits/ Inspections and manage the logistics for client and internal audits.

Provide guidance and review all deviations/CAPA, provide support in RCA and submit relevant documents and evidence to QA team.

Ensure all applicable CDP controls are updated on an ongoing basis. Perform monthly Pharma IT control checks.

Provide support for the Operations team to achieve 100% compliance with tasks as per client requirement.

Engage in CSV compliance activities at Engagement and Pharma level, as applicable

Qualification BSc,Bachelor of Pharmacy,Bachelor Degree in Life Sciences