QC Microbiology (Manager/Senior Manager)

Role Name: QC Microbiology (Manager/Senior Manager)

• Responsible for overall Microbiology functions and 24X7 inspection readiness to laboratory compliance & safety in the laboratory.
• To lead and manage the strategic and operational performance of the quality department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success.
• Responsible for implementing company quality ethics policy for data integrity and inform as per corporate data governance policy.
• To ensure OOS/OOT/OOC/MDD/Deviation/Laboratory incidents are adequately investigated, trended, evaluated and ensure that action items and corrective or preventive actions are identified, addressed, and successfully implemented.
• To ensure the quality systems are maintained in compliance with corporate standards.
• To support CQA for effective implementations of key cGMP initiatives undertaken by various CQA functions.
• To identify system implementation issues and resolves them within and between area management.
• To provide regulatory support on issues to submission/review response related to deficiencies related to analytical testing.
• To ensure all Pharmacopoeias updates for Microbiology general chapter, API, excipients, packing material and drug products
• To ensure adequacy of analytical method validations as per current regulations.
• To ensure stability data generated on submission batches are completed as per the requirements and to ensure compliance of abnormal trends on time.
• To ensure analytical instruments are meeting appropriate regulatory requirements and complying to 21 CFR part 11/EU Annex-11.
• To ensure contract analytical testing facilities are qualified as per regulatory requirement and corporate policies.
• To ensure that section of product testing, non-commercial testing, raw material, packing material, investigation OOS/OOT/MDD/OOC/Incident, lab support and microbiology complies with the regulatory requirement and corporate policies.
• To review quality index/ QUEST index for quality indicating parameters and compliance status of the quality control.
• To review & approve the calibration/stability schedule, working standards & primary standards COA's and release COAs (as applicable).
• To review stability protocols & reports and other qualification protocols & reports.
• To ensure adequate analytical support is provided for any investigation analysis and root cause established for all non-confirmed OOS/ OOT/ OOC (OOS and OOT due to laboratory errors).
• To review OOS/ OOT/ OOC/ Incident for its appropriateness and completeness. To suggest CAPA for laboratory failures as an outcome of OOS/ OOT/ OOC/ Incident investigation.
• To review all trend data (OOS/ OOT/ incidence, microbiological) and initiate appropriate actions wherever necessary in consultation with corporate quality if required.
• To ensure that appropriate measure are taken to prevent recurring of OOS/ OOT.
• To review change control, deviation and associated impact assessment.
• To ensure verification of calibration devices are done at approved, qualified, NABL accredited agency, government laboratory or equivalent laboratory.
• To coordinate with manufacturing/ GDSO/ Regulatory/ Quality Assurance for timely release of raw and packing materials, in-process, semi-finished and finished products.
• To ensure that adequate and appropriate glassware, chemicals, standards, culture media, microbial culture strain & other resources required for analysis are available in the laboratory.
• To ensure appropriate action is taken in case of data integrity issue and perform impact analysis.
• To coordinate with corporate quality for the implementation of applicable regulatory compliance points of other sites to his / her site.
• To ensure annual maintenance contract renewal and calibration of analytical instruments.
• To evaluate the complaint sample & report the result to quality assurance.
• To intimate immediately to Head Quality Control/Quality Assurance about the on-going commercial stability failure.
• To coordinate with external customers for laboratory related issues.
• To provide analytical support in investigations of market complaints and No Standard Quality (NSQ).
• Responsible for review of SOP's in DMS.
• Review/HOD approval in trackwise for QMS and investigation/risk assessment document.

• To represent Microbiology Department during customer as well as regulatory audits.
• To review compliance reports of regulatory audits.
• To conduct the GEMBA round at site and to prepare the site for external audits.
• To ensure Microbiology labs are compliant to cGMP by assessing the laboratory through periodic audits.
• Responsible to fulfill the compliance to audit commitments completion rate.
• To review the compliance response to the results of product quality system assessments by internal and external auditors and ensure execution as per timelines.
• To ensure implementation of global CAPA’s at sites.

• To ensure all stability samples analysis completed as per schedule and no stability samples are pending beyond timeline.
• To ensure on time analysis and disposition of RM, PM, in-process, finish product and stability samples
• To conduct the vendor audits as and when required.
• To conduct the self-inspection audit of all sites of Zydus.

• To ensure timely recruitment of resource and to place the right peoples at right place.
• To create KPI for sub-ordinates.
• To mentor and prepare second line as back up.
• To prepare the budget for the Microbiology.
• To ensure system users are qualified by establishing requirements and providing training content.
• To oversight assigned new projects are designed as per the expectations from Quality perspective and implemented as per the plan.
• To ensure adequate resource for training and qualification of analyst.

• To interact with R & D and Technology Development for quality development as per QbD guidance and provide necessary support for new products and projects with reference to development and scale up trials.

• To effectively implement new technologies, laboratory automation and other initiatives taken by corporate quality.