Senior Manager or Manager - Audit & Compliance Services

Prescription Pharma Support; Mumbai Suburban; In loco; INR 3.500.000 - 5.500.000; Tempo pieno

Descrizione del lavoro

Prescription Pharma Support is seeking a Senior Manager / Manager Audit & Compliance Services to lead on-site audits for clients in Europe & Asia from Kandivali, Mumbai. The role requires monitoring, reviewing, guiding, and supporting quality systems, with frequent client interface.

You will drive audit readiness, ensure CAPAs, and collaborate with cross-functional teams. A post‑graduate in chemistry/pharmacy with 10–15 years of audit experience and certifications (IRCA/ASQ/ICHQ7/APIC/PDA) are

Competenze

• Post Graduation in Chemistry/ Pharmacy or relevant pharmaceutical science/biochemistry.
• 10-15 years of relevant professional experience.
• Hands-on exposure to audits (face audits).
• Working knowledge of cGMPs and regulatory requirements; experience with EDQM, EU GMP, WHO, US FDA, PICS, MHRA, CANADA.
• Certification like IRCA/ASQ/ICHQ7/APIC/PDA is preferred.

Mansioni

• Conduct audits to identify gaps in facilities, processes, and equipment.
• Ensure on-time execution of audit tasks across projects.
• Address audit observations and ensure corrective/preventive actions.
• Interface with clients for audit & compliance and issue resolution.
• Maintain state of inspection readiness and guide client teams.
• Collaborate across teams to support audit & compliance services.

Conoscenze

Audits

cGMPs knowledge

Regulatory requirements

Teamwork

Change management

Client communication

Travel readiness

Formazione

Post graduate in Chemistry/Pharmacy or Pharmaceutical Science/Biochemistry

Descrizione del lavoro

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 environment 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.