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Friday, June 14, 2013

Corporate Quality Assurance Manager by Ajanta Pharma Limited in Mumbai

Job Description

1. shall review batch document and other quality system documents such as change control, deviation, OOS, rejects, etc.
2. Should initiate action plan and participate in complaint investigation
3. Should communicate and coordinate with different manufacturing sites, DRA, legal, marketing departments fro closure of complaints within stipulated period.
4. Should track and monitor the CAPA of the complaint and its implementation and its effectiveness.
5. should perform, analyse and prepare report of complaint trending and recommend improvements in the system

6. Shold identify the training needs out of the trend and provide the training to the concerned personnel.
7. Should monitor and update the complaint in electronic database.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Keyskills: Quality Assurance, Quality assurance testing, CAPA, Pharmacovigilance, OOS, CQA, Quality control, qa, quality manager

Desired Candidate Profile

Education: (UG - B.Pharma - Pharmacy, Diploma - Other Specialization) OR (PG - M.Sc - Chemistry, MBA/PGDM - Other Management, PG Diploma - Other) OR ( Doctorate - Doctorate Not Required)
1. Candidate should be B. Pharm/ M.Sc. (Chemistry) graduate.
2. Should have 10-13 years of experience in CQA / QA in pharmaceutical formulation manufacturing company
3. Candidate must have worked in regulated environment, involving manufacturing and marketing of drug products for countries like US, UK/ Europe, WHO and ROW (Anglo / French)
4. Preferably candidate shall have knowledge of manufacturing and QC aspects of various dosage forms such as solid dosage forms, liquid dosage forms, sterile dosage forms, MDI and topical dosage forms
5. Should have thorough understanding of regulatory requirements including D and C act (Indian FDA), US FDA or MHRA UK, and European requirements
6. Out of total experience, candidate shall have atleast 4-5 years of work experience in handling of market complaints deciding on investigation action plan, participation in investigation, preparation and review of detailed complaint report and initiation of CAPA and its implementation and closure of complaint.
7. Shall be able to review batch document and other quality system documents such as change control, deviation, OOS, rejects etc.
8. Exposure to or actual work experience in production, QC, RA is desirable
9. Knowledge or thorough understanding of quality systems would be desirable
10. Knowledge of pharmacovigilance and handling of ADR events would be desirable
11. Candidate having knowledge on cross functioning systems such as OOS, product recalls and technical agreements would be preferable.
12. Knowledge of veterinary, well being and cosmetic products.
13. Candidate must possess good written and verbal communication skill
14. Shall have hands-on operations of word, powerpoint and excel
15. Must lead investigations and closures in timely manner
16. Hands on experience on complaint management software and maintaining database

Company Profile

Ajanta Pharma Limited

Contact Details
Recruiter Name:Sanketa Pednekar
Contact Company:Ajanta Pharma Limited
Email Address:
Reference Id:APL/R&D/CQA/01

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