JOB DESCRIPTION:

Provide support to Quality Control Manager in managing QC activities related to Cleaning Validation, Computer System Validation and Annual PQR process.

Major Responsibilities:

• Prepare PQR (product Quality Review) Annual plan and implement it in timely manner.
• Collect PQR related data from all stakeholders, review and analyse data and prepare PQR report.
• Share PQR findings / observations / trends with respective sections and Senior Management for appropriate CAPA/recommendation.
• Cleaning Validation
• Preparation of Cleaning Validation Master Plan (CVMP), protocols and reports with worst case selection as per recent guidelines and products at site.
• To ensure Cleaning Validation activities related with Products, Processes, and Equipment.
• To provide support to QC in conducting glassware cleaning validation.
• Conduct Cleaning validation and revalidation via preparing cleaning validation protocols, relevant documentation as per Master plan.
• Perform and manage cleaning validation sampling activities along with QA support.
• Revision of cleaning validation schedule as per production and supply priority as per their request and consensus.
• Computer System Validation:
• Prepare annual Computer System Validation Master Plan (CSVMP) of QC equipment and ensure adherence, prepare, and communicate monthly computer system validation plan to all stake holders.
• Prepare protocols and reports of computer system validation and to perform computer system validation activity accordingly.
• General Responsibility:
• Review of applicable policies and align SOPs (related to PQR, cleaning validation, and computer system validation).
• Implementation and compliance of all the SOPs and applicable policies and procedures.
• To review and complete change control tasks with respect to Cleaning Validation, Computer System Validation and PQR.
• To prepare impact assessment and risk assessment as or when required.
• To provide support to other sections/departments with respect stability program and any data required for to PQR, Cleaning Validation, and Computer System Validation
• To review AQR LL, HPR and other quality projects for assessment and actions related to above-mentioned sections.
• To participate in self-inspection, Regional, Divisional and AQR Audits as an SME of above-mentioned sections.
• To implement Audit CAPAs of above-mentioned sections in timely manner
• Any other responsibility, assigned by Quality Control Manager or Head of Quality Assurance.
• As an SME support will be provided to Stability Section when required.

Education/Knowledge & Experience:

• M.Sc. Chemistry / Pharm-D
• 8-10 years’ experience in the same capacity 
• Knowledge of requirement for QC/QA activities, Cleaning Validation, Computer System Validation problem resolution skills and other all activities taking place in QC/QA including knowledge of Annual product quality review.
• Knowledge regarding Validation and Facility etc.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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