Job as Regulatory Affairs Manager - Semi & Non regulated markets in Leading Pharma | B.Pharm, M.Pharm, B.Sc, M.Sc

Leading Pharma co. with huge range of products ranging from sterile preparation to oral solid dosage forms with international markets.

Post: Regulatory Affairs Manager-Semi & Non regulated markets (1 opening, Male Candidates Preferred)

Job Description:
-Knowledge of Regulatory requirement for different countries (For Regulated / Non regulated Market)
- 5-10 years experience in Regulatory related work.
-Knowledge of latest guidelines of all countries
-Good coordination skill with related depart.

Candidates should be well versed in preparation of pdf dossiers in ACTD / CTD formats. Self initiative taking. Pro Active. CANDIDATES MUST HAVE EXPERIENCE IN NON REGULATED AND SEMI REGULATED MARKET
Should Manage all activities related to Product registration. Coordination with QA and Production people for dossier requirement. Awareness of preparation of COAs, Specifications etc.
Checking of RM COA recd. From suppliers. And Finish product COA recd. etc

Candidate Profile:
Qualification: B.Pharm, M.Pharm, B.Sc, M.Sc
Experience: 5-10 yrs exp handling Semi/non regulated markets.
Male candidates shall be preferred on priority as visiting FDA offices shall be in concern.

Additional Information:
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Experience: 5-10 yrs
Location: Andheri East, Mumbai
Industry: Pharma/Biotech
Key Skills: DRA
Last Date: 16th Feb, 2014

If the position interests you, kindly send across your updated CV (word format) at aspsol.recruitments@gmail.com
Kindly mention your current CTC, expected CTC and notice period. Also enclose your photograph with the application

Require Quality Control (QC) Specialist, Scientific and Medical Writing in Cactus Communications

CACTUS is a pioneering global scientific communications company. In everything we do, we want to accelerate the development of global scientific research, by helping science break through the confines of geography and language. To this end, we partner with academic and pharmaceutical communities worldwide and leverage the expertise of 1400+ professionals to create compelling, high-quality scientific communications. Browse through the tabs below for a closer look at CACTUS.

Post: Quality Control (QC) Specialist, Scientific and Medical Writing

Job description:
The medical writing team at Cactus works with multinational pharmaceutical companies, clinical research organizations, and researchers worldwide to help them communicate their science. We are currently looking to add to our team, an experienced QC specialist who wishes to be part of a world-class delivery team, and work in an exciting, fast-paced global environment

As part of his/her key responsibilities, the QC specialist at Cactus will

·         Fact check manuscripts, posters, slide decks, educational material, medical literature, etc, provided by clients for data accuracy

·         Check documents (mentioned above) developed by medical writers for scientific data errors by checking the developed material against annotated references, CSRs, other source data

·         Check for discrepancy within text, discrepancy between figures/tables, and between text and supplementary material

·         Identify missing sources documents and gaps in scientific logic

·         Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements

·         Be responsible for the quality of the documents/projects fact checked/QCed

·         Ensure effective communication of QC/fact check findings with the client/medical writers

·         Deliver QC reports to the stakeholders, and identify quality trends

·         Ensure 100% timely delivery of documents

Candidate Profile
This position requires:

·         Minimum 2 years of experience in the medical writing industry; fresher’s with substantial knowledge of the publication landscape and with published papers are also eligible

·         PhD or Master’s degree in Research, or equivalent industry experience

·         Ability to work efficiently and independently, multitask, and prioritize

·         Excellent attention to detail, and zero tolerance to errors

·         Ability to concentrate and work under pressure and meet tight deadlines

·         Excellent written and oral communication skills

·         Functional with Microsoft Word, Excel, and PowerPoint

·         Flexible and adaptable to changing project priorities and work assignments

Additional Information
Experience: Min. 2 Years
Qualification: M.Pharm, M.Sc
Functional Area: QC
Location: Mumbai
Last Date: 18^th Feb., 2013

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Opportunity to work in Roche as Senior Executive – Quality

At Roche, 82,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Diagnostics India, with a sales turnover of INR 150 crores, nurtures an open, flexible and challenging work environment, which allows for rapid career progression. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland — a great place to live and work.

Post: Senior Executive – Quality

Job Description: 
Creates and maintains processes/procedures for ensuring compliance to divisional guideline and local regulatory requirements
* Sets QM standard and documented processes required for supply chain quality
* Implements product labeling activity adhering to local regulatory guideline and global divisional Q standard.
* Helps in implementing quality guideline for local distribution practice
* Coordinates with warehousing, transport partners for adherence to quality guideline, validations, risk management. Helps in audit of warehouse.
* Helps in implementation of Post market surveillance standard, and responsible for Risk assessment and CAPA at affiliate level.
* Maintains QMS for local packaging Activity as per global QMS guideline as well as business requirement. Implement continues improvement in process and system
* Trains the employees on the quality aspects Monitors the process to ensure product quality as per the standards
* Assists Quality head to lead set and improvise quality system of organization.

Candidate Profile:
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

B.Sc. or B.Pharma with 4-6 years in the area of Product Quality & Safety

Preferred Experience: Minimum of 4-6 years’ experience in similar industry, preferably in IVDs or equivalent experience in OTC, Pharma or FMCG Preferably from MNC

Additional Information
Experience: 4-6 Years
Qualification: B.Sc, B.Pharm
Functional Area: QA
Job ID: 2767731557
Location: Mumbai- Maharashtra
Last Date: 15^th Feb., 2014

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Required DGM-Quality Assurance (API pharma background only) at Leading API/ bulk drugs company

Leading API/ bulk drugs co. having its own mfg plant at raigad

Post: DGM-Quality Assurance (API pharma background only)

Job Description:
1. Incumbent should be an MSc in Analytical Chemistry.
2. Have over 8-10 years of experience in QA function in an API pharma industry.
3. Excellent Communication skills. Well versed in Hindi, English and preferably in Marathi - both written & spoken.
4. Well versed with US FDA, Australian TGA, GMP etc., guidelines and documentation
5. Should have faced the international audits and resolved the queries.
6. A good leader and a team player alike.

Candidate Profile:
Candidates willing to relocate to Mahad may only apply.
Excellent Communication skills. Well versed in Hindi, English and preferably in Marathi - both written & spoken.
We are looking out to hire candidates with MSc Analytical Chemistry background with min. 8-12 yrs exp in API Pharma QA

Additional Information:
Education: MSc (Chemistry)
Experience: 8-15 yrs
Location: Raigad, Maharashtra
Industry: Pharma/Biotech
Key Skills: API, manager, QA, quality assurance
Salary Range: 12.0 to 15.0 lacs per annum
Last Date: 16th Feb, 2014

If the position interests you, kindly send across your updated CV (word format) at aspsol.recruitments@gmail.com
Kindly mention your current CTC, expected CTC and notice period. Also enclose your photograph with the application

Work as QA Documentation Executive - 2 posts | Aspiring-Solutions hiring for its pharma client

Leading API pharma co. Aspiring-Solutions hiring for its pharma client

Post: QA Documentation Executive - 2 posts

Job Responsibilities:
1. Incumbent should be a BSc with first class.
2. Candidate should have experience From an API pharma industry.
3. Excellent Communication skills. Well versed in Hindi, English and preferably in Marathi - both written & spoken.
4. Knowledge of US FDA, Australian TGA, GMP etc., guidelines and documentation
5. Should have faced the international audits and resolved the queries.
6. Expert in Microsoft word for generation of GMP documents like SOP, BMR, BPR etc
7.QMS expert in Excel for APQR preparation and other documentation
8. Should be willing to relocate to Mahad and join asap.

Additional Information:
Education: BSc (First Class)
Experience: 2-5 yrs
Location: Mahad, Maharashtra
Industry: Pharma/Biotech
Key Skills: API, documentation, QA, quality assurance
Salary Range: 2.0 - 3.5 lacs per annum
Last Date: 16th Feb, 2014

If the position interests you, kindly send across your updated CV (word format) at, aspsol.recruitments@gmail.com
Kindly mention your current etc, expected etc and notice period. Also enclose your photograph with the application