Executive

• Planning and Execution of all MMD-I & BPR preparation activity pertaining to Main Pharma Block, Cephalosporin Block, Penicillin Block & Rifampicin Block of Dholka, as well as Contract Manufacturing & Herbal.
• Preparation and review of MMD-I & BPR of
• Main Pharma Block
• Cephalosporin Block
• Penicillin Block
• Rifampicin Block
• Contract Manufacturing
• Herbal
• Initiate and review of change control, deviation & CAPA.
• Preparation of SOP pertaining to functioning of the department.
• Preparation of MMD-I & BPR of ANDA market.
• Intra as well as inter department co-ordination with respect to preparation, review & approval of MMD-I & BPR.
• To create ZFRT codes for Export market (Dholka, Jammu & Jammu2) in Master Data Management (MDM).
• To create ZHLB code for Export & Domestic market (Dholka, Jammu & Jammu2) in Master Data Management (MDM).
• To create & update BOM of ZHLB & ZFRT codes for Export & Domestic market in Master Data Management (MDM).
• To co-ordinate with Production, SCM, QC, RA, Tax, Purchase, Finance & IT departments for SAP/MDM related issue.
• Any other jobs assigned by Head QA.

• Responsible for review, tracking and closing of deviation, change control and CAPA in LIMS.
• Responsible for participating in investigation along with cross functional team to find out actual root cause of incident or deviation.
• Responsible for review and assign number to Deviation, Change control, CAPA when required supporting documents is available in system.
• To ensure the completion, closing and effectiveness of CAPA given to the different regulatory and customer audit.
• Responsible to take follow up with cross functional team to approval & closing of deviation, change control, CAPA.
• To check the effectiveness of implemented change control and CAPA as required.
• Responsible for review of manufacturing investigation.
• Responsible for handling of Market complaints. Perform investigation and report preparation.
• Responsible for review of manufacturing investigation.
• Responsible for preparation and review of Risk assessment.
• Responsible for logging of conversion note.
• Responsible for preparation of Trend analysis report for QMS records as per SOP.
• Responsible for review change control, deviation and CAPA logs from system.
• Responsible for handling of recall procedures.
• To prepare and revise the departmental SOP and ensure training to all concerns.
• To perform mock recall and documented all the activity within timeline as mention in the schedule.
• To assist for any other jobs assigned from time to time.
• Responsible for FAR handling and sharing investigation report for register market complaints.
• To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM.
• Perform effective self-inspection as per schedule and ensure timely closing with proper CAPA or justification for the noncompliance found during self-inspection.
• To participate in all internal and external audits.
• To prepare compliance report of different customer and regulatory audits.
• To make sure that internal and external audit compliance report is prepared within given timeline.