1. C. Rajamani Iyer, MSc (Microbiology) MBA(IB)
Bangalore India Mobile: 91-9590785841 E mail: manimicroin@yahoo.co.in
Page 1 of 6
Objective
To achieve new heights of excellence through the sustainable, compliant solutions complimenting
progressive organizational goals that offer opportunities to unleash my skills, creativity, and
commitment through quality for the transformation of organization from compliance to
competitive advantage.
Profile
Senior Quality assurance manager with 15 Years of experience in Pharmaceutical Regulatory
organization. Active member in Participating into regulatory audits like MHRA, TGA, Health
Canada and USFDA certification. Comprehensive Knowledge in sterile & Non-sterile formulation.
Area of expertise
Quality Assurance / Manufacturing Assurance/Analytical Assurance/Process Audits/ Site Quality /
Handling Customer Complaints/Supplier Audits/ Quality Management System/ Supplier
management /Microbiological Technique
World's seventh-largest
Pharmaceutical company
measured in Prescription drug
sales, Operation over 108
countries
Senior Quality Assurance
Manager
Level E (May 15-till date )
Bangalore ,India
Team Management:
10 member team responsible for Deviation, change
management, Training and capability development, supplier
and depo management.
Job description
 QA final approval role for SOPs and Instructions (AZ
Doc), Change control, Deviation, CAPA approval
(Track wise System), Validation and qualification
documents.
 Management Systems of Quality Management Systems:
 Supervisory responsibilities like Work instruction and
training to team members, Build and develop team
capability, Provide daily performance feedback to team
members, Conduct formal performance evaluations to
staff, Ensure the team member receive enough GMP
training.
 Internal/External GMP Inspection responsibilities like
Prepare annual self-inspection plan, Develop internal
audit system and ensure its implementation, Develop
internal auditor capability, Take leader auditor role in
self-inspection, Follow up and assess, review and
approval of CAPA and its effectiveness, Identify the
quality improvement area with risk based approach,
Leading or coordinate external GMP inspections to
ensure no critical deficiencies.

2. C. Rajamani Iyer, MSc (Microbiology) MBA(IB)
Bangalore India Mobile: 91-9590785841 E mail: manimicroin@yahoo.co.in
Page 2 of 6
International
Training/conference:
Attended five days training on
QMS in Shanghai.
Attended five days GES(Global
External Sourcing)
conference/meeting in UK
 Ensure continuing suitability and effectiveness of the
quality management system, product quality and
GMP/GDP compliance through participation in
management reviews and through advocating continual
improvement.
 To be responsible for product release and ensure that the
manufacturing and testing of every product batch is
compliant with related regulations, marketing
authorization and quality specification;
 Monitoring of compliance with the requirements of
Good Manufacturing Practice.
 To ensure all quality related changes are assessed and
approved, To ensure the investigation and handling of
deviation and OOS;
 In charge of the recall issues, To ensure GMP
principles/procedures were promoted within the facility;
 To ensure the surveillance of the quality control
department. To ensure Adverse drug reaction reporting.
 Execution of Quality council meeting and Escalation site
KPI(Key Performance Indicator)
Ongoing Project :
 QCM Localization.
 Batch record & SOP simplification.
 e-archival implementation,
 EU GMP Part II compliance.
 Audit readiness Program
 BMR/SOP Simplification
 Data Integrity Project
Completed Project :
 Involved in Global projects on “Management of AMV”
in line with ICH and Co-ordination with RA (Jan 15
onwards-June15)
 Gap analysis on RS compliance with respect to AZ
guideline and initiation of RS method validation at the
supplier end (June 14 –June 15) .This includes review
and finalization of limit.

3. C. Rajamani Iyer, MSc (Microbiology) MBA(IB)
Bangalore India Mobile: 91-9590785841 E mail: manimicroin@yahoo.co.in
Page 3 of 6
Work accomplishments
 Introduction of Gazelle system in 51 artwork on primary
and secondary artworks of Gazelle. For this
“MAD”(making a difference ) award was received as a
token of appreciation.
 Implementation of Linear barcode for supplier
Packaging materials in 39 SKU within 10 months
period.
 Participation in Global batch release Procedure
integration.
 Received certificate of appreciation from QA Head of
Asia Pacific for Enhancing the Quality culture.
Supplier Manager QA
Level D
Global External Sourcing(GES)
March 13-Apr 15
 Planning for audits, tracking of Regulatory Agency
inspections and impact assessment of audits.
 Serve as GES representative on Issue Management
Teams.
 Provide expert QA input to new product introduction.
This includes assessing of identified Suppliers,
establishing supply and supporting through to regulatory
approval. (Selection-establishment-maintenance –
Termination)
 Maintains an understanding of relevant production
processes and quality systems.
 Performs the QA review and/or approval of cGMP
documentation
 Collaborates in data analysis and report creation on
quality metrics and key performance indicators as
appropriate.
 Develops and maintains effective business relationships
with Suppliers and AZ receiving sites.
 Responsible to maintain the relationship with 6 FP
suppliers, 11 manufacturing sites, 3 API sites and in total
35 SKUs of FP.
 Current supplier management includes the product from
sterile FP, non-sterile FP and API.
 Involved in due-diligence activities to assess the quality
standards of suppliers in India prior to deals.
 e Management of Quality systems viz. Deviation,
Change control (OCM), Complaints (GCM), Corrective

4. C. Rajamani Iyer, MSc (Microbiology) MBA(IB)
Bangalore India Mobile: 91-9590785841 E mail: manimicroin@yahoo.co.in
Page 4 of 6
and Preventive actions, QSRs through the Track wise,
Batch release through SAP, Vendor management by
SCA database, Artwork management by GAZEL, Audit
and CAPA management through GAMS.
 Establish the KPIs, Quality Management Systems and
governance structure for the new business in line with
AZs quality standards.
 knowledge of Quality Management competencies such
as auditing, quality engineering, root cause analysis,
FMEA, design control, project management,
specification and stability management
Business is spread across 54
countries
Manager QA(Site QA Head )
Bangalore, Unit III
Oct 2010 to March 2013
 The site QA team consists of 16 personnel responsible
for various activities, include but not limited to
validation, IPQA, Batch release, QMS, Investigation and
customer relationship.
 Identifying training needs and execution of training as
per schedule.
 Handling of audits includes external, regulatory, internal
and supplier audits.
 Ensuring the implementation of CAPA (Corrective and
preventive action) from change control, deviation,
customer complaints and audit (customer /regulatory).
 Disposition of deviation, Change control, OOS and
OOT.
 Review and compliance of site cGMP.
 Reporting to VP Corporate Quality.
Work accomplishments
 Independently handled the MHRA and TGA during Feb
2011, March 13.
 Handled various customers (around 25) requirement as a
site QA lead.
 Significant reduction of market complaints from 75
numbers in year 2011 to 45 number in year 2012.

5. C. Rajamani Iyer, MSc (Microbiology) MBA(IB)
Bangalore India Mobile: 91-9590785841 E mail: manimicroin@yahoo.co.in
Page 5 of 6
Asst. Manager QA
Pondicherry, Formulation
Jan 2005 to Oct 2010
 Shasun venture in to Formulation (OSD) manufacturing
on 2005 and Joined during the project stage in QA
department.
 HVAC Qualification Protocol and Report preparation.
Execution of IQ, OQ and PQ along with the Utility
Person and ensuring its compliance.
 Review of Water system Validation Protocol and
Participation in the Execution as per the Protocol. Data
collection, compilation and Preparation of trend data for
Raw Water, DM Water and Purified water. (Phase I to
Phase III).
 Preparation and execution of Area Qualification
Protocol, reports Compilation.
 Validation of Production equipment related to the
Tablets manufacturing.
 Preparation of cleaning /Process validation protocol and
report.
 Involved in tablets IPQA activities.
 Preparation and review of QMS documentation.
Executive QC Microbiologist
Unit 12 sterile formulations
December 2003 - December
2004.
Junior Scientific officer
Panelav Division from October
2001 - Nov 2003.
Trainee chemist
Sterile formulation
After the completion of Msc Applied microbiology joined with
Gland as QC Microbiologist on July 2000.
Up to December 2004 worked as Microbiologist in there
Sterile facilities. Good understanding level of microbiological
technique as stated below ,
 Review of microbiological report like raw material,
finished product analysis report, water analysis report
and environmental monitoring report.
 Preparation of microbiological environmental and water
analysis trend. Microbial limit test method validation as
per different pharmacopoeia.
 Sterility test method validation., Bioburden mapping
validation.
 Bioassay method validation. Sterile facility qualification.
 Disinfectant efficacy validation.
 Perform hold time validation of sterilized articles.
 Bacterial Endotoxin test

6. C. Rajamani Iyer, MSc (Microbiology) MBA(IB)
Bangalore India Mobile: 91-9590785841 E mail: manimicroin@yahoo.co.in
Page 6 of 6
July 2000 – September 2001  Environmental Monitoring of classified area in
injectable manufacturing unit.
 Involvement in failure investigation pertaining to
microbiology.
Education Profile
 Bachelor Bio- Chemistry(Regular)
 Master in Applied Microbiology(Regular)
 International Business(Distance education)
Personnel details
Gender Male
Marital status Married
Reference
Mr.Sreenevasa Reddy
VP Operation
Strides Shasun Formulation
+91 9342201476
Mr.Sudhir Gouder
Novartis Singapore
+6591680786
Mr. Anil Mummigatti,
VP Quality
Windlas Dehradun
+91 9902113782
Mr. Jayakumar
GM QA
Apex laboratories
+91 9443987152
Mr.Shankar Narayanan
Mylan
+91 9972026575