Cadila Pharmaceuticals
Deputy Manager
- Compensation
- Not disclosed
- Location
- Dholka
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Full 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. • 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.