Job Description

• 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. o Preparation and review of MMD-I & BPR of o Main Pharma Block o Cephalosporin Block o Penicillin Block o Rifampicin Block o Contract Manufacturing o Herbal o Initiate and review of change control, deviation & CAPA. o Preparation of SOP pertaining to functioning of the department. o Preparation of MMD-I & BPR of ANDA market. o Intra as well as inter department co-ordination with respect to preparation, review & approval of MMD-I & BPR. o To create ZFRT codes for Export market (Dholka, Jammu & Jammu2) in Master Data Management (MDM). o To create ZHLB code for Export & Domestic market (Dholka, Jammu & Jammu2) in Master Data Management (MDM). o To create & update BOM of ZHLB & ZFRT codes for Export & Domestic market in Master Data Management (MDM). o To co-ordinate with Production, SCM, QC, RA, Tax, Purchase, Finance & IT departments for SAP/MDM related issue. o Any other jobs assigned by Head QA. o To perform vendor management activity to assure that vendors are complying with Cadila procedure on vendor management and GMP requirements in order to source quality materials and products. o To perform self-inspection activity to assure that the facility remains in the state of cGMP compliance, to evaluate and identify gaps for future needs and to regularly review the effectiveness and applicability of the quality assurance system. o Responsible to assist for handing of day to day activities related to Vendor Approval. o To assist for evaluation of vendor documents and maintain current status. o To assist for preparing vendor grading of RM/PM based on rejection of supply from vendors on yearly basis. o To assist for providing required documents of vendor to cross functional team. o To assist for transfer of RM/PM stock in SAP, due to on-line rejection. o To assist for submission of the vendor samples to QC and maintain log of Sample Register. o To assist for intimation of RM/PM rejection to purchase department for CAPA and maintenance of RM/PM rejection tracking Sheet. o Responsible to assist for create & update of Raw Material & Packing Material vendors in SAP. o To perform vendor audits for vendor qualification as per requirement of RM/PM. o To maintain quality agreements with manufacturers and contract manufacturing parties. o To prepare and review of Site Master File and Quality Manual. o To prepare and review of excipients risk assessments. o Handling of Quality Management system (QMS). o To co-ordinate and perform the Self-inspection activity at the Site. o To prepare auditors list for self-inspection activity and conduct training program for auditors. o To prepare audit report, review compliance report, logbook updation, follow-up for the CAPA and to ensure effective implementation of CAPA. o Preparation, Review, Issuance, Revision, Control and Retrieval of SOP pertaining to functioning of the department. o To assist for any other jobs assigned from time to time by HOD. 1. Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities. 2. To Perform Vendor Management Activity to assure that Vendors are Complying with Cadila SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products. 3. To perform the validation exercises of new as well as existing equipment's, utilities and critical systems. 4. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports. 5. Preparation of SOPs pertaining to qualification and Validation activities. 6. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks. 7. To prepare, review, execute and compile the protocol and report of Transportation Validation. 8. To Performed FAT(Factory Acceptance Test), SAT(Site Acceptance Test). 9. Coordination with cross functional teams for smooth conduction of validation activities with respect to: o Equipment Qualification / Re-Qualification, Validation / Re-Validation o HVAC System Validation and Utility Validation o Temperature Mapping Study of critical area 10. To initiate and review change control, deviation and CAPA 11. To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies 12. Any other jobs assigned from time to time. o To ensure compliance of Validation, Qualification, Re-Qualification and Re-Validation activities as per schedule pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities. o Planning and execution of Process Validation, Packing Validation, Transportation Validation and Cleaning Validation activities pertaining to Dholka site in line with the cGMP requirements of national and international regulatory authorities. o To prepare, review and approve SOP's., Validation & Qualification protocols and reports. o To perform the validation exercises of new as well as existing equipment's, utilities and critical systems. o Coordination with cross functional teams for smooth conduction of validation activities with respect to: - Equipment Qualification / Re-Qualification, Validation / Re-Validation - HVAC System Validation and Utility Validation - Temperature Mapping Study of critical area - Process Validation of new product as well as existing products - Hold Time Study - Packing Validation, Transportation Validation of products - Cleaning Validation o Coordinate and participate in Aseptic Process Simulation (Media fill) Studies. o To review and approve CAPA, Deviation & Change Control. o To ensure smooth technology transfer of new product to plant level sign the Technical agreement with customer. o To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks. o To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all such international quality standards. o To ensure that the product meets the defined standards for strength, identity, safety, purity and quality by various system-driven approaches. o To appoint the qualified staff for technical function and ensuring their technical and overall development through systematic training processes and reviewing their performance periodically. o Ensure proper implementation of corporate policies / guidelines. o To participate various regulatory / customer audits and ensure the compliances of Audit observation. o To ensure cGMP related training program for all concerned manpower. o Responsible to assist for handing of activities related to Vendor Approval. o To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM. o To prepare, review, execute and compile the protocol and report of Process Validation. o To prepare, review, execute and compile the protocol and report of Hold Time Study. o To prepare, review, execute and compile the protocol and report of Packing Validation. o To prepare, review, execute and compile the protocol and report of Transportation Validation. o To prepare, review, execute and compile the protocol and report of Cleaning Validation. o Any other jobs assigned from time to time."

Skills Required