1. Covering Letter
Dear Sir/Madam,
I am SK.Sikander having 5+ years of experience in QA(QMS,IPQA) departments. Having hand full of
experience in different formulations like Injectable, Tablets, Capsules and pellets.
Present working in Dr.Reddys labs ltd as an Associates in Quality Assurance department, Hyderabad,
AP, India.
I have completed my B-Pharmacy and my profile is adequate for your requirement.
My complete CV is enclosed here under in detail …...
Hence, I request you to give me an opportunity to dish up your esteemed organization and my career.
Thanking you.
Sk.Sikander.
2. SSKK..SSIIKKAANNDDEERR
· sikkir0046@gmail.com Experience: 5+ years.
· +91 9951 000 110, +91 8520 005 540.
Objective
Seeking a challenging career to excel my performance. Looking forward for an opportunity to work in a
well-projected environment where my knowledge can be shared and enriched.
Educational Qualification
B. Pharmacy from Annamacharya College of Pharmacy, Rajampet, Kadapa Dt, affiliated to JNTU
Hyderabad , during the year 2003 - 2007.
Career Summary
F Having 5+ years of Professional experience in QA department in Injectable, Tablets, Capsules and
Pellets Formulations companies. (Approved by USFDA, ANVISA, WHO, MHRA and other
regulatory bodies.)
QA-Associate, Injectable -- DR.REDDY’S Labs Limited -- July-2013 to till date.
Hyderabad, AP. India. (1.6 years)
QA-Officer, OSD -- HETERO Labs Limited -- Nov-2009 to June 2013.
Hyderabad, AP. India. (3.8Years)
Job description:
F IPQA: 3+ years
To give line clearance at various stages of manufacturing, packing and in Dispensing, and
ensure the process is followed as per standards.
In process checking to ensure that manufacturing & packing operations are carried out as per
the laid down procedures adhering to cGMP.
Sampling of in-process, bulk, finished products, retention samples and Submission of stability
samples to QC laboratory as per the protocol.
Sterile.
Monitoring of Component preparation area, Sterilization process, and Compounding,
Filtration, Filling, Optical Inspection, and Labeling& Packing activities.
Review and aseptic execution of Media Fill Protocols.
Bulk release procedure, Reconciliation and control.
PH meter, Conductivity meter, Centrifuge, Versa Test Apparatus (For measurement of Break
loose and glide forces in case of Pre Filled Syringes).
Measurement of dissolved oxygen, head space oxygen.
Sealing integrity checking using centrifuge, Leak test using desiccator.
Performing AQL.
Ensuring the proof check during startup of the packing activities
Performing pack stock activities in packing.
Monitoring ware-house activities.
Final review of BMRs, BPRs and Analytical reports for giving FGTN.
3. Batch release in SAP.
Verification of Documents and consignment before dispatch..
Execution of Process Validation, Cleaning Validation and Hold time study as per the
protocol.
On hands experience in formulation calculations.
F QMS: 2+years
Control, issue and retrieve of SOPs.
Responsible and monitoring of Incidents, Deviation, CAPA and Change controls.
Conducting internal audits and monitoring observations of all depts.
Training Coordinator: Conducting trainings (Planned, unplanned, On-the-job….) by TRIMS
Software.
Preparation and final review of Annual Product Quality Review.
Collection, review and submissions of documents to RA-D according to check list for Dossier.
Responsible for Superseding of old documents.
Involved in preparation of cleaning and process validation protocols and reports.
Involved in preparation of BMRs and BPRs
Responsible for control, issue and retrieval of formats, Registers and other Doc.
Responsible to arrange for submitting respective completed documents for audits.
Equipment’s Capable to Handle (PLC)
Fluid Bed Coater (R&D FBC to 500kg FBC),
System Exposer
Operating System: Windows (98/2000/XP), MS-DOS.
Application System: MS-Office.
Trims and SAP.
Area of Interest
QA, RA.
Strengths
Excellent Communication Skills, Hard working nature, Professional Culture.
Coordination with the people in a professional manner.
Flexibility to work hard for long hours and patient enough until the goal I accomplish.
Personal Dossier
Father Name : S. Mahaboob Basha. Languages known :English, Hindi and Telugu.
Marital Status : Unmarried. Pass port number :H412534
Date of Birth : 31st March of 1986. Permanent Address :D.No.4/86A,Usman nager,
Rajampet(post), Kadapa, Pin-516115. AP.India.
Declaration
I hereby declare that all the information mentioned above is true to the best of my knowledge.
Yours Sincerely,
SK.Sikander.