Admin - Kolkata

About Company:

A leading Indian Active Pharmaceutical Ingredient (API) manufacturer specializing in hormones and steroid-based intermediates. The company operates a state-of-the-art manufacturing facility near Kolkata, West Bengal, and serves global pharmaceutical markets including the United States, Europe, Japan, Latin America, Australia, and Africa.

An Ideal Candidate:

The Administration Manager is responsible for overseeing facility management, housekeeping, security, compliance, and administrative operations in a regulated pharmaceutical/API manufacturing environment. The role ensures continuous audit readiness in line with cGMP, USFDA, and data integrity requirements while maintaining efficient and compliant site operations.

Language Requirement

• Good communication skills in Hindi and English are mandatory.

• Proficiency in Bengali will be an added advantage.

Key Competencies:

· Ensure proper zoning, access control, and regulatory-compliant signage across the facility.

---

B. Housekeeping & Contamination Control

· Implement and monitor housekeeping systems aligned with contamination control and data integrity principles.

· Ensure strict adherence to cleaning SOPs.

· Maintain cleaning logs, vendor training records, and audit trails.

· Ensure proper segregation practices and support cleaning validation where applicable.

---

C. USFDA Audit Readiness & Compliance

· Maintain site-wide readiness for USFDA and regulatory inspections at all times.

· Ensure all administrative areas (offices, record rooms, common areas) are inspection-ready.

· Support preparation and maintenance of:

o Site Master File inputs (admin sections)

o Facility layouts, diagrams, and zoning maps

o Vendor qualification documentation

· Ensure:

o Controlled document archival systems with traceability

o No unauthorized materials/documents in GMP areas

· Train admin and contract staff on GMP practices, data integrity, and audit etiquette.

· Participate in mock audits, identify gaps, and ensure timely closure.

· Ensure compliance with ALCOA+ principles in all administrative records.

---

D. Security & Access Control

· Implement robust access control systems aligned with regulatory and data integrity expectations.

· Maintain accurate records of:

o Personnel entry and exit

o Material movement

o Visitor management

· Ensure proper recording of all gate entries and security logs.

· Oversee CCTV and surveillance systems for effective monitoring and compliance.

---

E. Statutory & Regulatory Compliance

· Ensure compliance with applicable laws and regulations, including:

o Factory Act

o Fire Safety regulations

· Maintain all licenses, permits, and statutory records in audit-ready condition.

· Coordinate with regulatory authorities during inspections and audits.

---

F. Vendor & Contract Management

· Qualify and manage vendors in line with GMP and compliance expectations.

· Ensure all service providers (housekeeping, security, pest control, etc.) are:

o Properly trained in GMP and safety practices

o Compliant with site procedures

· Maintain vendor agreements, performance evaluations, and audit records.

---

G. Documentation & Record Control

· Ensure proper control, storage, and retrieval of administrative documentation.

· Maintain logs such as:

o Visitor registers

o Cleaning records

o Facility maintenance logs (admin scope)

· Ensure all records comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

---

H. Canteen & Employee Welfare

· Ensure canteen operations meet hygiene and GMP standards.

· Monitor employee facilities to prevent contamination risks.

· Manage employee services including transport, uniforms, and change room facilities.

---

I. EHS Coordination

· Coordinate with EHS for:

o Handling and disposal logistics of hazardous and hormonal waste

o Emergency preparedness (fire drills, evacuation plans)

· Provide administrative support during incident investigations and regulatory reporting.

· Manage disposal of general waste and sale of scrap generated at site.

---

J. Budgeting & Cost Control

· Prepare and manage the administration budget.

· Monitor and optimize costs without compromising compliance or audit readiness.

---

2. Key Performance Indicators (KPIs)

· Successful USFDA and regulatory inspections with zero critical observations (Admin scope)

· Audit readiness status with no major gaps

· Compliance with housekeeping and facility standards