Team Leader - Microbiology - Sterile

Cipla; South Goa District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Cipla in Goa seeks a Quality Assurance professional in Microbiology to review investigations at sites, track CAPA, and contribute to Sterile Quality Matrix reviews. You will harmonize microbiology procedures across Cipla sites, participate in vendor audits, and prepare SOPs and technical guidance documents in line with cGMP and GLP.

This role requires strong documentation, regulatory understanding, and coordination with site microbiology heads and contract labs.

Responsibilities

• Track and review investigations performed by sites.
• Track and compile for Sterile Quality Matrix Review meetings and share pre-reads on time.
• Prepare and revise policy documents, testing procedures, method validation procedures, and Technical Guidance SOPs per GMP/GLP.
• Harmonize Microbiological Procedures across Cipla sites and units.
• Provide comments on SOPs, policy documents, testing procedures, and unit QC procedures.
• Handle CipDox, emSigner and Trackwise based on user roles.
• Review unit investigations, trend summaries and in-house isolate data.
• Prepare scientific rationale per guidelines, pharmacopoeias and regulatory requirements.
• Vendor audits: prepare audit agenda, conduct audits of critical consumables, and prepare reports.
• Take up projects: SOP/Protocol for disinfectant efficacy tests; coordinate with contract labs; review raw data and test reports; track vendor approvals.

Job description

Job Purpose

To review investigation performed by sites, track and compile for sterile Quality Matrix review in addition to auditing critical consumable vendors, preparing high standards of Corporate Microbiology documents, and execute new projects for Microbiology from Corporate by having complete understanding of the requirements for Microbiology best practices as per the regulatory guidelines.

Key Accountabilities

Track and review investigations performed by sites.

• To track all types of investigations initiated by sites and to ensure investigations are closed timely with appropriate root cause and CAPA.

Track and compile for Sterile Quality Matrix Review

• To track and compile all necessary details required for Sterile Quality Matrix Review meetings and ensure that the pre-read is shared timely.

Preparation and revision of policy documents, testing procedures, method validation procedures, Technical Guidance SOPs with respect to current guidelines, pharmacopoeias, regulatory requirements and in compliance with current Good Manufacturing Practices and Good Laboratory Practices.

• To harmonize and simplify Microbiological Procedures across all Cipla sites and associated units.
• To provide comments on Technical Guidance SOPs, policy documents, testing procedures, method validation procedures, Unit Quality Control Procedures etc, which are common for both chemical and microbiology departments.
• Handling of softwares such as CipDox, emSigner and Trackwise based on the roles and rights provided in the system.
• To review documents prepared by other team member on behalf of Department Head / Section Head.
• To review unit investigations, trend summaries and inhouse isolate data.
• To prepare Scientific Rationale respect to current guidelines, pharmacopoeias, regulatory requirements.

Effectiveness Check of SOPs

• To ensure that the Corporate SOPs are understood and followed by the users at site.
• To identify any enhancement / improvements required in Corporate SOP.

Vendor audits

• To prepare audit agenda for critical consumables
• To conduct Vendor Audit of Critical Consumable
• To prepare audit report

Take up projects based on requirement

• To prepare SOP / Protocol for disinfectant efficacy test
• Planning and coordination for disinfectant efficacy test with contract laboratories
• Review of raw data and test report for appropriateness of results observed
• Track vendor approval of all critical consumables used in Microbiology laboratory
• Provide support to vendor team for identification and evaluation of critical consumables.

Major Challenges

• To identify gaps in investigations that could lead to inappropriate root cause and CAPA and to make sites understand for appropriate action.
• To coordinate with site microbiology heads and convince for changes in Corporate SOPs with respect to current guidelines, pharmacopoeias and regulatory requirements.
• To identify gaps in documents executed by sites and convince site microbiology of the corrections required.
• To explain to vendor of critical consumables the cGMP requirement, to ensure that they are followed and relevant documents are provided for verification and record.
• To explain Cipla microbiology testing requirements to contract testing laboratory and ensure all requirement of Cipla are met.