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 environment 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 professional 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