Team Member

Division
Department
Sub Department 1
Job Purpose
Support R&D and manufacturing unit by on time provision of specifications, preparation of standards, Pharmacoepeial collaboration and Toxicity predictions for time bound development of the project

Key Accountabilities (1/6)
Review development specifications in order to provide support to Unit QC for finalization of CCDC specifications and submission of competent qualitative monographs to Local and International pharmacopoeias to monopolise Cipla's products in regions under the jurisdiction of the corresponding pharmacopoeia

• Develop specifications for APIs, RMs and Intermediates
• Method of Analysis and Certificate of Analysis
• Review monographs to ensure that it fulfils all the criteria's required for submission

Key Accountabilities (2/6)
Predict Genotoxic impurities for API R&D molecules and interaction with the Vendor for Genotoxic prediction of molecules in order to support R&D and Unit ADL for method development.

• Predict and interpret Genotoxic impurities for easier understanding
• Arrange structures from R&D and Unit ADL to Vendors for Toxicity prediction

Key Accountabilities (3/6)
Prepare and maintain Laboratory standards and review data for providing compliance to regulatory and FDA norms which entails checking and monitoring Laboratory, safety and documentation practise

• Prepare and maintain Laboratory standards such as Test Standards, Volumetric standards, GC standards which also includes reference standards like USPRS and EPCRS
• Review Lab notebooks, IQ, OQ, PQ, Stability reports, deficiency reports, Characterization data

Key Accountabilities (4/6)
Prepare SOPs/ EOPs/ IOPs for maintaining GLP and GDP timely with data integrity

• Take Approval on the change requests
• Prepare SOPs/ EOPs/ IOP's for existing quality systems
• Collate all the comments received from other units and the R&D team
• Plan and incorporate innovative ideas to implement new SOPs
• Impart training on SOPs and electronic systems
• Prepare and maintain in-house, external calibration schedule and preventive maintenance schedule
• Review of external and internal calibration reports.
• Maintain breakdown records of instruments and equipment
• Prepare and finalise the qualification documents and URS
• Prepare internal quality related audits and finance audits and provide compliance for the same
• Handle change controls, deviations, incidence
• Prepare job responsibilities and updates on organogram
• Issue project code
• Check and maintain the logs, Eg. R&D log book issuance log, MPG issuance log, pilot requisition forms, analytical method validation checklists, batch number, PDS issuance and submission.
• Check R & D record books, training files

Key Accountabilities (5/6)
Execute on time technology transfer of projects to transferring unit which entails co-ordination with the cross-functional teams of other units and relevant documentation of product life cycle

• Prepare the Master Process Guidelines and related documents for TT
• Acquire data from R & D and ADL team to prepare the documents
• Collate all the comments received from pilot and unit on the process
• Co-ordinate with cross-functional teams after the technology transfer of the projects
• Prepare the Strategy documents and QbD documents, Project closure forms and development reports
• Prepare and compile TT file for Audits
• Prepare, maintain and archive PDS for API process

Key Accountabilities (6/6)
Major Challenges
Time taken from the cross-functional teams for getting approval on change requests To overcome frequent follow-ups taken to get approval

Getting prompt compliance from R & D team,To overcomecommunicate and take follow –ups.

Key Interactions (1/2)

• Internal stakeholders for data required by Formulation department for strategy

preparation (need basis)

• Manufacturing units by providing development specifications, standards, data and compendial updates (need basis)
• DQA/ CQA for approval on change requests (need basis)
• Accounts for accounts related queries (need basis)

Safety Auditors
for audits and giving compliance (need basis)

Key Interactions (2/2)

• Outsourcing partners for on time deliverables such as V life for toxicity prediction (need basis)
• Pharmacopoeial authorities for collaboration across the globe (need basis)
• External Calibration Parties and Instrument/equipment service Providers for the qualification and calibration related activities (need basis)
• External finance auditors for asset related audits (need basis)

Dimensions (1/2)

• TAT for review of Unit ADL development specifications: 2 days
• TAT for preparation of development specifications/ MoAs: 2 days
• TAT for compliance review of characterization report : 2 days
• TAT for compliance review of deficiency report : 2 days
• TAT for preparation of Test standards: 2 days.
• TAT for sending pharmacopoeial queries: 2 days.
• TAT for Non-chromeleon Data integrity :1 Day
• TAT for Compendial updates:1 Day
• TAT for review of Laboratory Notebooks: 1 Day
• TAT for Analytical strategy review: 1 Day
• Rework for Monograph preparation : less than 3 rectifications per Monograph
• Rework for preparation of specification/ MoA: less than 3 rectifications per specification/ MoA
• Technology related Documentation ( range 5-10 )
• Development Reports(1-5)
• Strategy documents(5-10)
• SOP's, EOP's, IOP's(10-15)
• PDS(1-5)

Change requests

Dimensions (2/2)
Key Decisions (1/2)
Critical decisions required for inclusion and

exclusion of tests in the development specification

Selection of monographs with ANDA approval for

pharmacopoeial submission

Finalization of specification and Test Standards

Key Decisions (2/2)
Approval on Unit ADL specification (to reporting manager)

Final monograph submission (to pharmacopoeial

Authority)

Education Qualification
M.Sc. (Analytical or Organic or Inorganic)

Relevant Work Experience
Minimum 5-6 years of ADL experience. Good communication and co-ordination skills with Analytical knowledge