Senior Associate/Team Lead-Quality Assurance(QA)

Job Responsibilities

• To ensure QMS are in place at CML in line with GMP requirements / Quality standards / applicable regulatory requirements.
• To review and identify the critical control points for each product and to ensure respective process controls are implemented at CML.
• To ensure products are manufactured, tested, and released at CMLs as per approved batch records & specifications.
• To provide support to CML’s to achieve all time GMP compliance.
• To ensure all current version of forwarded documents are used for manufacturing and testing of products.
• To keep track of all CAPAs and review the CAPA implementation status so that Quality sustainability is achieved.
• Responsible for identification, assessment, and mitigation of risks at CMLs.
• To participate in any new product Trials /Technology transfers /Site transfers at new /existing sites.
• To investigate product failures, market complaints, non -conformances with root cause analysis & ensure robust CAPA’s is defined.
• To ensure completion of activities in line with Quality Road map.
• Maintaining master list of documents and ensuring implementation of current version of below documents:

1.Batch records (BMR / BPR)

2.Specifications, STP’s, GTP’s (RM / PM/ FG)

3.Artwork & Shade cards

• Identification & escalation of gaps in manufacturing / packing process between BMR / BPR Vs Actual.
• To review practices and data of Environmental, Water trends, cleaning validation, etc. on Monthly basis.
• To review the Analytical data, logbooks, instrumentation data to ensure CMLs are performing analysis as per approved test methods.
• To perform terminal inspection for the batches in-warded at respective CML/CFA/Mother warehouse.
• To share the discrepancies of terminal inspection to Compliance team at CML and to follow-up for investigation reports and CAPA of the same.
• To share the terminal inspection reports to HWC – HO.
• Trending of terminal inspection data – Location wise and share the trends to Compliance team at CML and HWC-HO.
• Escalate any Non-conformance/ Deviation from standard procedures/ GMP violations which lead to business risk / product Quality to HOD-QA.
• Any other Job responsibilities assigned by the Reporting Manager.