Senior Executive QA (M07) - Capsule Division
- Custom Capsules
- 10 - 15 years
- Boisar
- 3 months ago
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Job Description
Role & responsibilities
You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company.
Key Deliverables:
1. Ensure manufacturing practices as per cGMP and GLP standards.
2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc.
3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.)
4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits.
5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG)
6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers.
7. Assisting HOD in customer complaint analysis and preparation of customer complaint report.
8. Investigation of incidents, deviations, OOS and ensure corrective actions in place.
9. Reviewing the daily availability of operators and allocating work to them.
10. Maintaining and review BMR documents, guide for relevant changes if required.
11. Label artwork review and management.
Technical Competencies:
a) Analytical skills (spotting trends and patterns)
b) Report writing skills
c) Problem solving abilities
d) GMP and GDP knowledge
e) Good English communication skills (verbal & written).
Behavioural Competencies:
a) Quality and Service Orientation
b) Delivering consistent results
c) Ability to prioritize, organize, manage work and time.
d) Customer Centric
e) Cross Functional Team Working
Preferred candidate profile
B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology)
8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries.
Perks and benefits
1. Opportunity to be part of a growing organization offering niche products to Pharma industry.
2. Opportunity to work at Head Office location.
3. Intimate small company culture with MNC professionalism.
4. Company value programs TrANSSCEnD.
5. Employee events like festival celebrations, family fun events etc.
6. Five days working (alternate weeks).
7. Medical Insurance for your immediate family.
8. Housing accommodation for Bachelors & family.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Custom CapsulesLocation(s): Boisar
Keyskills: Validation CAPA QMS deviation GMP USFDA ISO Audit APQR
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