osition - Senior Manager / Manager Audit & Compliance Services

Kandivali - West, Mumbai

Report to - Business Head

Job Purpose and Key Responsibilities:

The purpose of this role is to take responsibility for Audit & Compliance Services to be provided by PPS for its Clients based in Europe & Asia.

The role of the Senior Manager / Manager, Audit & Compliance services, is to work on the site of client to Monitor, Review, Guide, Audit and Support Quality System.

Key responsibilities include:
Conduct Audits to identify the gaps in the facility, process, equipment
On time execution of the tasks within a project or on multiple projects
Completing the tasks as per the requirement as defined by the agreement/project head, client requirement and as per regulatory requirements
Ensure aconstant state of inspection readiness and allAudit observations are addressed
Interface with client for Audit & compliance and resolution of issues.
Ensure that corrective and preventative actions are completed for all the observations noted during document review and/or noted during Audits conducted by PPS at clients site.
Play the role of an effective communication link between various Audit and client




Will be working in a dynamic and pressurised setting and must be experienced in a change setting and should be able to inspire the client with guidance
High level of involvement is required with the ability to manage multiple small tasks simultaneously.

Basic Requirement
Academic Qualification minimum): Post Graduation Chemistry/ Pharmacy or Relevant Pharmaceutical Science/Biochemistry. Years of relevant qualified experience: 10 - 15 years.
Should have hands on exposure to face Audits
Working knowledge of cGMPs, regulatory requirements and previous experience on conducting GMP Audits.
Hands on exposure to & conversantwith the requirements of international regulatory agencies such as EDQM, EUGMP, WHO, USFDA, PICS, MHRA, CANADA.
The ability to work within a team and manage Audits & compliance services with our clients.
Knowledge of the pharmaceutical industry with multidisciplinary is the most preferred.
Candidate with Innovative and Creative thoughts
Should have certification like IRCA / ASQ / ICHQ7 / APIC / PDA etc.
Candidates with passion towards performing Audit & compliance services and willing to travel.

📌 Senior Manager Or Manager Audit & Compliance Services Mumbai
🏢 Prescription Pharma Support
📍 Mumbai