Assistant Manager

Ciron Drugs & Pharmaceuticals; Boisar; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Ciron Drugs & Pharmaceuticals in India seeks an experienced IPQA Lead to supervise shop floor IPQA activities in sterile manufacturing, authorize line clearances, and ensure compliance with GMP norms. The role involves monitoring aseptic practices, leading CAPA actions, and reviewing key quality records.

The candidate should have 7–12 years of core IPQA experience in sterile injectable facilities, with B.Pharm/M.Pharm or M.Sc in Chemistry/Microbiology.

Qualifications

• Experience in IPQA for sterile injectable/parenteral facilities.
• Strong leadership of IPQA Executives and Officers.
• Exposure to regulatory inspections and CAPA processes.

Responsibilities

• Shop Floor Oversight: supervise IPQA activities in sterile manufacturing areas.
• Authorize line clearance and area clearance to prevent cross-contamination.
• Monitor aseptic practices, gowning qualifications, and media fills.
• Review EM data, particle counts, and cleanroom interventions.
• Lead on-floor investigations for deviations, OOS/OOT, CAPA actions.
• Review and approve BMR, BPR, SOPs, protocols, and logbooks.
• Oversee process and cleaning validation; qualify critical machinery.
• Maintain audit readiness for WHO-GMP inspections.
• Mentor and train IPQA team; ensure safety and shift coverage.

Skills

Shop Floor Oversight

Line Clearances

Sterility Assurance & Media Fills

Environmental Monitoring

QMS Investigations

Document Review & Approval

Validation & Qualification

Audit Readiness

Team Leadership

Education

B.Pharm

M.Pharm

M.Sc in Chemistry

M.Sc in Microbiology

Tools

Autoclaves

Tunnel

Lyophilizers

Job description

Role & responsibilities .

• Shop Floor Oversight: Supervise day-to-day IPQA activities in sterile/aseptic manufacturing areas, including dispensing, compounding, vial/ampoule filling, lyophilization, sealing, and visual inspection.
• Line Clearances: Authorize line clearance and area clearance before commencing different operations to ensure zero cross-contamination risks.
• Sterility Assurance & Media Fills: Monitor aseptic practices, cleanroom behavior, personnel gowning qualifications, and actively participate in Aseptic Process Simulations (Media Fills).
• Environmental Monitoring (EM): Review cleanroom environmental monitoring data, viable/non-viable particle counts, and oversight of interventions in Grade A/B zones.
• QMS Investigations: Lead on-floor investigations for deviations, non-conformances, OOS/OOT results, and ensure the implementation of effective CAPA (Corrective and Preventive Actions).
• Document Review & Approval: Review and approve online Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), standard operating procedures (SOPs), protocols, and equipment logbooks.
• Validation & Qualification: Provide QA oversight during process validation, cleaning validation, and qualification of critical sterile machinery (e.g., Autoclaves, Tunnel, Lyophilizers).
• Audit Readiness: Maintain shop floor audit readiness for stringent regulatory inspections ( WHO-GMP) and participate in handling audit queries.
• Team Leadership: Guide, mentor, and train a team of IPQA Executives and Officers, ensuring proper shift allocation and adherence to safety protocols

Preferred candidate profile

• Education: B.Pharm / M.Pharm or M.Sc. in Chemistry/Microbiology from a recognised university.
• Experience: 7 to 12 years of core IPQA experience specifically in a Sterile Injectable / Parenteral facility.