Site Quality Head - Formulation

Role & responsibilities

Major Activities / Tasks

Implement robust Quality system and procedure at site as per cGMP requirement for compliance readiness of site

• Devise internal controls for Gap assessment
• Organise the Quality management reviews meeting with CFT team to demonstrate the awareness
• Approve SOPs as per the regulatory guidelines

Plan and monitor the quality control activities in all the laboratories of a site by conducting periodic meetings / interactions and reviewing status of batch release and related lab activities to ensure all technical issues are resolved in time for smooth laboratory operations

• Oversee on-time testing of input materials, in-process, finish products, validation, stability etc. samples at each laboratory of site to ensure QC batch releases as per Standard Lead Times
• Ensure timely completion of non-routine activities like qualification, calibration, non-routine validation at each lab by regularly reviewing lab operations
• Monitor on-time completion of QC tech transfer and other activities for timely filing and smooth execution products launches from site
• Review the quality score, SRB score of all labs to ensure all activities within control
• Oversee the implementation of Orbit initiatives for excellence in quality testing in lab operations

Ensure timely release of finished products with quality standard as per marketing authorization to deliver safe end product to the customer

• Monitor weekly releases of finished products within SLA and as per release criteria
• Monitor closure of all deviations/ OOS timely and with adequate CAPA
• Approve planned deviations at site

Ensure the availability of adequate resources by evaluating the need of instruments, equipment required at site for smooth functioning of QC operations to meet production plan and achieve manufacturing OTIF within time and budget

• Monitor quality manpower and operating expense for each laboratory to meet budget
• Review the need of assets, facility requirements in laboratory to reduce the outside testing, up-gradation of lab facilities, new product requirement etc.
• Evaluate and approve CERs raised for assets needed in laboratory, selection of appropriate technique, manufacturer model etc.
• Ensure adequate stock of glassware, chemicals and consumables maintained and supplied by common store to quality control
• Approve costly indents raised from common store to ensure minimum inventory and control cost

Drive people development by spearheading tactical and strategic initiatives within the quality control function at a site in order to maximize performance and achieve better control of operations

• Identify the training needs of employees based on the updates in the pharmacopeial guidelines
• Monitor the training imparted on laboratory techniques, quality control procedures and principles of cGMP & GLP
• Drive continuous improvements by implementing good practices at the site in order to achieve good output and cost savings
• Increase team accountability by clearly outlining expectations and ways of working
• Liaise with HR for driving goal setting process, performance review and grievance redressal of the team

Establish mechanism to monitor the Quality Budget through an excel based tracker for providing best in class quality in the prescribed budget

• Organise the periodic joint review meeting of Quality team with accounts team to check expenses on OpEx and manpower cost
• Recommend approval of PRs, CRs and manpower cost to senior management
• Control wastage of consumables and resources by rationalizing the need and monitoring for optimum usage

Plan and coordinate regulatory and customer inspections for smooth & compliant outcome leading to business enhancement

• Conduct opening meeting with the auditors
• Plan the audit strategy as per the agenda
• Identify proactively, the risk areas and decide on the severity of the observation
• Ensure the online compliance to the Quality observations are done by providing solutions and guiding the expectations of the inspector
• Verify the compliance adequacy & CAPA effectiveness as per the regulatory expectation to avoid recurrence of the

observation

Preferred candidate profile

Degree in Pharmacy/ MSc with 15-25 Years of experience

Recruiter Details

Mohaneswara Reddy (Cipla Kurkumbh TA Head)

https://www.linkedin.com/in/mohaneswarareddy