Quality Compliance Associate

Job Title: Quality Compliance Associate

Experience: 1-2 years
Location: HyderabadNotice Period: 0-15 daysPreferred Industry: Medical / Pharmaceutical Industry

Brief Description:

The Quality Compliance Associate provides core compliance functions and project support for the Quality Compliance department including SOP document preparation and updates, training file maintenance, and compliance audits. Audit support includes, but is not limited to, audit scheduling, logistics, and document preparation and support. The Quality Compliance Associate provides additional assistance with special projects including CAPA document management, compliance-related continuous improvement projects and training document creation/updates within the Learning Management System (LMS). This position may also provide administrative support to the Quality Compliance department as appropriate.

Specific job duties:

· Ensure SOPs and corresponding test assessments are created and updated within a timely manner according to internal policies and procedures. Ensure appropriate formatting of SOP documents.

· Support and management of the Quality Management Systems (QMS) to include:

o Problem Notification Forms (PNFs)

o Corrective/Preventive Actions (CAPAs)

o Compliance Audits (Client/Vendor/Internal)

o Document Management (SOPs/PSPs/WIs/Job Aids)

· Support SOP review and approval process as deemed appropriate

· Provide Regulatory/Client Audit Supporto Assist with audit scheduling and audit calendar maintenanceo Assist with meeting coordination/logistics

§ CDA Requests

§ Auditor Code of Conduct

§ Setting up internal trackers and portals

§ Setting up and providing secure Box access for auditor(s) when required

o Assist with Quality Compliance documentation review prior to and during audit.

o Ensure audit reports and responses are stored as per Project record retention procedures.

· Provide assistance with Problem Notification Form (PNF) and CAPA data entry and administrative review when required.

· Provide administrative support (i.e., agenda, minutes, metrics) for the Quality Assurance department.

· Support the maintenance and archival of all QA records.

· Assist in department-related special projects.

· Assist with Learning Management System document management where needed.

· Other duties as assigned.Supervisory

Responsibility:

Qualifications:· Bachelor’s degree or equivalent work experience.

· 1 – 2 years of relevant experience preferably within a regulated pharmaceutical and/or medical device industry.

· Proficient PC knowledge required including Microsoft Office Suite and Internet, SharePoint.

· Excellent written and oral communication skills essential for professional phone and email interactions.

· Good interpersonal skills.

· Continual attention to detail in composing, typing and proofing materials, establishing priorities and meeting deadlines.

· Ability to work independently.

· Strong organizational and time management skills.

· Ability to interact and work within a team environment.

· Ability to keep sensitive information confidential.

· Preferred experience working within the bounds of Standard Operating Procedures/policies.

Job Type: Full-time

Pay: ₹200,000.00 - ₹500,000.00 per year

Work Location: In person