:

• 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.

📌 Executive (Dholka)
🏢 DigiCAD
📍 Dholka